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  • outbreak
  • Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the deadly fungal meningitis outbreak that took place in late 2012. (mondaq.com)
  • The U.S. Food and Drug Administration (FDA) issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA), which Congress enacted in November 2013, as part of the Drug Quality and Security Act (DQSA), in response to the deadly fungal meningitis outbreak that took place in late 2012. (mondaq.com)
  • The company at the center of the deadly fungal meningitis outbreak has been under increased oversight since a 2006 inspection of its pharmacy labs discovered widespread deficiencies in protocols for manufacturing drugs. (newsinferno.com)
  • On October 9, 2012, members of the United States Congress asked federal health officials for briefings on the outbreak as a first step toward possible legislative action to strengthen federal drug safety regulations. (wikipedia.org)
  • On November 14, 2012, members of a congressional committee investigating the outbreak accused the Food and Drug Administration (FDA) of failing to prevent the crisis by moving too slowly against the Massachusetts pharmacy. (wikipedia.org)
  • FDA's
  • Congress, through section 503(A) of the Food, Drug and Cosmetic Act, already recognizes FDA's responsibility to oversee some compounding activities. (pewtrusts.org)
  • According to FDA officials, these inconsistent decisions and the agency's limited inspection authority over pharmacies have created challenges in FDA's ability to inspect and take enforcement action against entities engaging in drug compounding. (unt.edu)
  • For example, from 2002 through 2012, in order to inspect some facilities engaged in drug compounding, FDA officials said they had to obtain 11 warrants to gain access to drug compounders' facilities that had challenged FDA's inspection authority. (unt.edu)
  • These policy documents aim to clarify FDA's expectations and enable the compounding industry to comply with the CQA. (mondaq.com)
  • In this interim guidance, FDA detailed its expectations for cGMPs at outsourcing facilities, which reflect FDA's position that compounding outsourcing facilities require different cGMPs than conventional drug manufacturers. (mondaq.com)
  • meningitis
  • The current estimate is that as many as 14,000 patients nationwide received potentially tainted drugs and more than 400 have developed meningitis, including 128 in Michigan, 52 in Indiana, 11 in Minnesota and two in Illinois. (chicagotribune.com)
  • Federal health officials have drastically increased the amount of confirmed cases of fungal meningitis linked to the use of a contaminated vial of an epidural steroid drug injection. (newsinferno.com)
  • chemical compounds
  • This is a basic tool for making novel chemical compounds, and it should have a wide range of applications," said Jin-Quan Yu, PhD, a professor at Scripps Research and senior author of the new report, published in the June 28, 2012 issue of the journal Nature . (medindia.net)
  • Chemical similarity (or molecular similarity) refers to the similarity of chemical elements, molecules or chemical compounds with respect to either structural or functional qualities, i.e. the effect that the chemical compound has on reaction partners in inorganic or biological settings. (wikipedia.org)
  • It plays an important role in modern approaches to predicting the properties of chemical compounds, designing chemicals with a predefined set of properties and, especially, in conducting drug design studies by screening large databases containing structures of available (or potentially available) chemicals. (wikipedia.org)
  • Examples for inverse distance measures are molecule kernels, that measure the structural similarity of chemical compounds. (wikipedia.org)
  • Semantic similarity compares chemical compounds based on their semantic characterizations. (wikipedia.org)
  • molecules
  • The technique enables chemists to add new functional molecules to previously hard-to-reach positions on existing compounds making it easier for them to generate new drugs and other organic chemicals. (medindia.net)
  • Capillary Electrophoresis (CE) was explored as a means for physicochemical and biopharmaceutical characterisation of small drug molecules. (diva-portal.org)
  • Some mechanisms of drug resistance include: Cell wall: The cell wall of M. tuberculosis (TB) contains complex lipid molecules which act as a barrier to stop drugs from entering the cell. (wikipedia.org)
  • Drug modifying & inactivating enzymes: The TB genome codes for enzymes (proteins) that inactivate drug molecules. (wikipedia.org)
  • Drug efflux systems: The TB cell contains molecular systems that actively pump drug molecules out of the cell. (wikipedia.org)
  • Drug delivery to the brain is the process of passing therapeutically active molecules across the blood-brain barrier for the purpose of treating brain maladies. (wikipedia.org)
  • agency's
  • FDA commissioner Margret Hamburg testified that the agency's efforts to address problems at the compounding center had been hamstrung by Congressional interference, conflicting court rulings regarding FDA jurisdiction, and tenacious litigation by the compounding center itself. (wikipedia.org)
  • lipophilic
  • Special attention was paid to the characterisation of acid-base and lipophilic properties of drug compounds by analysing their migration behaviour in different CE systems. (diva-portal.org)
  • This is surprising because one would think that the most effective way to make a drug move through a lipophilic barrier is to increase its lipophilicity, it turns out that it is a complex function of all of these characteristics that makes a drug able to pass through the blood-brain barrier. (wikipedia.org)
  • Cosmetic Act
  • Title I of the Drug Quality and Security Act, the Compounding Quality Act, would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. (wikipedia.org)
  • The courts have agreed with the FDA that the Food, Drug, and Cosmetic Act (FDCA) requires information not only on how a product is to be used (e.g., dosage and administration), but also on all the intended uses of the product. (wikipedia.org)
  • bacteria
  • Vanderbilt biochemists have discovered that the process bacteria undergo when they become drug resistant can act as a powerful tool for drug discovery. (phys.org)
  • However, beginning with the first antibiotic treatment for TB in 1943, some strains of the TB bacteria developed resistance to the standard drugs through genetic changes (see mechanisms. (wikipedia.org)
  • The TB bacteria has natural defenses against some drugs, and can acquire drug resistance through genetic mutations. (wikipedia.org)
  • Mutations: Spontaneous mutations in the TB genome can alter proteins which are the target of drugs, making the bacteria drug resistant. (wikipedia.org)
  • Applications discussed range from measurement of slow oxidative degradation of polymers and instability of hazardous industrial chemicals to detection of bacteria in urine and evaluation of the effects of drugs on parasitic worms. (wikipedia.org)
  • physicians
  • Though physicians may prescribe drugs for off-label usage known as off-label marketing, the Food and Drug Administration (FDA) prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved. (wikipedia.org)
  • adverse
  • The principal markets for the Torsion Balances were with the retail druggist who used it in compounding prescriptions, and with users who needed a precision weighing device that could be used under adverse conditions that would quickly ruin balances with knife edges or friction bearings. (wikipedia.org)
  • The bill would require a facility to report biannually to the United States Secretary of Health and Human Services (Secretary) on what drugs are compounded in the facility and to submit adverse event reports. (wikipedia.org)
  • CDI is actively engaged in a number of large-scale iPS cell reprogramming and banking projects, with the goal of creating broadly available resources of iPS cells that represent normal human diversity, disease states and adverse drug reactions. (wikipedia.org)
  • injections
  • For example, three people in Oregon and Washington who died after receiving drugs from Texas - intravenous injections for back pain that were eight times the labeled strength. (pewtrusts.org)
  • In the NECC case, the approved medication for back injections is suspected of being contaminated with fungus during the compounding process. (chicagotribune.com)
  • In April 2012, the FDA received reports of eye infections in patients given injections of Franck's drug products containing triamcinolone during eye surgery. (newsinferno.com)
  • Officials at Franck's previously issued a statement indicating that they conducted a thorough investigation, tracing the contamination to a dye used in ocular triamcinolone injections and formulas containing that drug. (newsinferno.com)
  • patients
  • While many more years of work must be done to test these new compounds in other models and, eventually, in human patients, the work demonstrates a new approach to treating endometriosis and other disorders tied to estrogen signaling and inflammation, the researchers said. (illinois.edu)
  • urges
  • The FDA Commissioner also stated, "In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding. (wikipedia.org)
  • medication
  • The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. (drugs.com)
  • This assumes, of course, that the physician intends that the medication be compounded. (wikipedia.org)
  • illegal
  • The FDA also previously accused Franck's of illegally developing copies of similar drugs, of creating so-called "brews" outside of federal guidelines, and of compounding animal products from drugs not approved for use in the U.S. Franck's was warned in 2005 and, again, in 2009, for illegal animal drug compounding. (newsinferno.com)
  • compounders
  • FDA expects 503A compounders to comply with the current list of drug products that cannot be compounded because they have been withdrawn or removed from the market due to safety or efficacy concerns. (mondaq.com)
  • practice
  • These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. (wikipedia.org)
  • Good Manufacturing Practice (GMP) Violations Off Label Marketing Best Price Fraud CME Fraud Medicaid Price Reporting Manufactured Compound Drugs Involve fraud with the Good Manufacturing Practice (GMP) Regulations which require manufacturers to have adequately equipped manufacturing facilities, adequately trained personnel, stringent control over the manufacturing process, appropriate laboratory controls, complete and accurate records, reports, appropriate finished product examination, and so on. (wikipedia.org)
  • regulation
  • Because thalidomide was never approved for use in the United States, fewer than 50 of those infants were born here.Single-handedly, Kelsey prevented a nationwide tragedy, provided a model for effective government drug regulation and changed the culture and mission of the FDA. (chicagotribune.com)
  • Federal drug regulation demands a delicate balance. (chicagotribune.com)
  • novel
  • A new high-throughput screening technique developed by researchers at the RIKEN Plant Science Center (PSC) has been used to uncover five novel immune-priming compounds in Arabidopsis plants. (phys.org)
  • The novel or designer metabolites produced by fungal endophytes are increasingly recognized by natural chemists due to their diverse structures and as candidates for drug discovery and development. (springer.com)
  • medicines
  • Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. (drugs.com)
  • respectively
  • The new compounds, OBHS (oxabicycloheptene sulfonate) and CLI (chloroindazole), interact with two types of estrogen receptors (ER-alpha and ER-beta, respectively). (illinois.edu)
  • The methodology was successfully applied for two sets of drug compounds, labile at low and high pH, respectively. (diva-portal.org)
  • The company will specifically make their products nifurtimox and suramin, the drugs of choice for the disease respectively, doubly accessible in South America and Africa, where the diseases are prevalent. (wikipedia.org)
  • safety
  • In recent months, this committee has repeatedly stressed the responsibility of FDA to ensure the safety of activities that depart from traditional compounding and are more akin to manufacturing. (pewtrusts.org)
  • CDI began to develop drug compound safety applications early in the company's product development cycle. (wikipedia.org)
  • advances
  • Here we update on the advances made on identifying bioactive metabolites with drug development potential from endophytic fungi. (springer.com)
  • Food
  • That would have happened had it not been for one physician working for the Food and Drug Administration, a brave woman largely forgotten today, named Dr. Frances Kelsey. (chicagotribune.com)
  • Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew's Birmingham metal-on-metal hip implant. (newsinferno.com)
  • products
  • FDA will not enforce the 5 percent cap on the distribution of compounded drug products outside of a 503A compounder's state until FDA finalizes a formal memorandum of understanding (MOU) with the states and allows time for the states' consideration and execution of the MOU. (mondaq.com)
  • Our main emphasis lies on the anti-infective discovery in the view of developing new drug compounds from endophytic products. (springer.com)
  • Title II of the bill, the Drug Supply Chain Security Act (DSCSA), would establish requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. (wikipedia.org)
  • Several published studies have used CDI products to investigate mechanisms of toxicity and have leveraged cellular models to identify toxicity earlier in the drug development process. (wikipedia.org)
  • CDI's products are used in high throughput screens, and have been used as supporting data in Investigational New Drug (IND) submissions to the FDA. (wikipedia.org)
  • CDI's iCell and MyCell products are being used to research the development of regenerative medicine approaches, including: regenerative medicine compound screening, allogeneic and autologous cell therapy, tissue engineering, and transplantation. (wikipedia.org)
  • scientists
  • In the late 1950s, German scientists developed a "wonder drug" for women that was supposed to alleviate the morning sickness, insomnia and headaches of pregnancy. (chicagotribune.com)
  • Scientists at The Scripps Research Institute (TSRI) have invented a set of chemical tools that is radically simplifying the creation of potential new drug compounds. (phys.org)
  • Two new drug compounds - one of which has already proven useful in a mouse model of multiple sclerosis - appear to be effective in treating endometriosis, a disorder that, like MS, is driven by estrogen and inflammation, scientists report in Science Translational Medicine. (illinois.edu)
  • known
  • The chemical compound known as "methylene blue" is a potential candidate for treating Alzheimer's, as it prevents the harmful clumping of so-called tau proteins typically associated with this disease. (phys.org)
  • They began by looking at compounds whose blood-brain permeability was known and labeled them either CNS+ or CNS- for compounds that easily transverse the barrier and those that did not. (wikipedia.org)
  • CJC-1295, also known as DAC:GRF (short for drug affinity complex:growth hormone-releasing factor), is a synthetic analogue of growth hormone-releasing hormone (GHRH) (also known as growth hormone-releasing factor (GRF)) and a growth hormone secretagogue (GHS) which was developed by ConjuChem Biotechnologies. (wikipedia.org)
  • functional
  • Compared to the traditional method, in which chemists modify only the existing functional groups on a compound, CH activation more directly boosts the complexity of a compound, giving it potentially valuable new properties. (medindia.net)
  • we think that we can apply our technique to many compound classes and functional groups. (medindia.net)
  • proteins
  • Another cause of this would be the binding to other proteins in the body rendering the drug ineffective to either be therapeutically active or able to pass through the barrier with the adhered protein. (wikipedia.org)
  • molecular
  • To achieve high efficacy of similarity-based screening of databases containing millions of compounds, molecular structures are usually represented by molecular screens (structural keys) or by fixed-size or variable-size molecular fingerprints. (wikipedia.org)
  • barrier
  • Because of the difficulty for drugs to pass through the blood-brain barrier, a study was conducted to determine the factors that influence a compound's ability to transverse the blood-brain barrier. (wikipedia.org)
  • lipophilicity is not the leading characteristic for a drug to pass through the barrier. (wikipedia.org)
  • They found that there is not a simple answer to what compounds transverse the blood-brain barrier and what does not. (wikipedia.org)
  • The first of these is that a lot of times, even if a compound transverses the barrier, it does not do it in a way that the drug is in a therapeutically relevant concentration. (wikipedia.org)
  • This can have many causes, the most simple being that the way the drug was produced only allows a small amount to pass through the barrier. (wikipedia.org)
  • decrease
  • In order to decrease the amounts owed to states under the Medicaid Drug Rebate Program, some companies misrepresented material facts regarding the regulatory origin/status of their brand name drugs, the AMP, and/or the best price. (wikipedia.org)
  • outbreak
  • Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the deadly fungal meningitis outbreak that took place in late 2012. (mondaq.com)
  • The U.S. Food and Drug Administration (FDA) issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA), which Congress enacted in November 2013, as part of the Drug Quality and Security Act (DQSA), in response to the deadly fungal meningitis outbreak that took place in late 2012. (mondaq.com)
  • The company at the center of the deadly fungal meningitis outbreak has been under increased oversight since a 2006 inspection of its pharmacy labs discovered widespread deficiencies in protocols for manufacturing drugs. (newsinferno.com)
  • On October 9, 2012, members of the United States Congress asked federal health officials for briefings on the outbreak as a first step toward possible legislative action to strengthen federal drug safety regulations. (wikipedia.org)
  • On November 14, 2012, members of a congressional committee investigating the outbreak accused the Food and Drug Administration (FDA) of failing to prevent the crisis by moving too slowly against the Massachusetts pharmacy. (wikipedia.org)
  • FDA's
  • Congress, through section 503(A) of the Food, Drug and Cosmetic Act, already recognizes FDA's responsibility to oversee some compounding activities. (pewtrusts.org)
  • According to FDA officials, these inconsistent decisions and the agency's limited inspection authority over pharmacies have created challenges in FDA's ability to inspect and take enforcement action against entities engaging in drug compounding. (unt.edu)
  • For example, from 2002 through 2012, in order to inspect some facilities engaged in drug compounding, FDA officials said they had to obtain 11 warrants to gain access to drug compounders' facilities that had challenged FDA's inspection authority. (unt.edu)
  • These policy documents aim to clarify FDA's expectations and enable the compounding industry to comply with the CQA. (mondaq.com)
  • In this interim guidance, FDA detailed its expectations for cGMPs at outsourcing facilities, which reflect FDA's position that compounding outsourcing facilities require different cGMPs than conventional drug manufacturers. (mondaq.com)
  • meningitis
  • The current estimate is that as many as 14,000 patients nationwide received potentially tainted drugs and more than 400 have developed meningitis, including 128 in Michigan, 52 in Indiana, 11 in Minnesota and two in Illinois. (chicagotribune.com)
  • Federal health officials have drastically increased the amount of confirmed cases of fungal meningitis linked to the use of a contaminated vial of an epidural steroid drug injection. (newsinferno.com)
  • chemical compounds
  • This is a basic tool for making novel chemical compounds, and it should have a wide range of applications," said Jin-Quan Yu, PhD, a professor at Scripps Research and senior author of the new report, published in the June 28, 2012 issue of the journal Nature . (medindia.net)
  • Chemical similarity (or molecular similarity) refers to the similarity of chemical elements, molecules or chemical compounds with respect to either structural or functional qualities, i.e. the effect that the chemical compound has on reaction partners in inorganic or biological settings. (wikipedia.org)
  • It plays an important role in modern approaches to predicting the properties of chemical compounds, designing chemicals with a predefined set of properties and, especially, in conducting drug design studies by screening large databases containing structures of available (or potentially available) chemicals. (wikipedia.org)
  • Examples for inverse distance measures are molecule kernels, that measure the structural similarity of chemical compounds. (wikipedia.org)
  • Semantic similarity compares chemical compounds based on their semantic characterizations. (wikipedia.org)
  • molecules
  • The technique enables chemists to add new functional molecules to previously hard-to-reach positions on existing compounds making it easier for them to generate new drugs and other organic chemicals. (medindia.net)
  • Capillary Electrophoresis (CE) was explored as a means for physicochemical and biopharmaceutical characterisation of small drug molecules. (diva-portal.org)
  • Some mechanisms of drug resistance include: Cell wall: The cell wall of M. tuberculosis (TB) contains complex lipid molecules which act as a barrier to stop drugs from entering the cell. (wikipedia.org)
  • Drug modifying & inactivating enzymes: The TB genome codes for enzymes (proteins) that inactivate drug molecules. (wikipedia.org)
  • Drug efflux systems: The TB cell contains molecular systems that actively pump drug molecules out of the cell. (wikipedia.org)
  • Drug delivery to the brain is the process of passing therapeutically active molecules across the blood-brain barrier for the purpose of treating brain maladies. (wikipedia.org)
  • agency's
  • FDA commissioner Margret Hamburg testified that the agency's efforts to address problems at the compounding center had been hamstrung by Congressional interference, conflicting court rulings regarding FDA jurisdiction, and tenacious litigation by the compounding center itself. (wikipedia.org)
  • lipophilic
  • Special attention was paid to the characterisation of acid-base and lipophilic properties of drug compounds by analysing their migration behaviour in different CE systems. (diva-portal.org)
  • This is surprising because one would think that the most effective way to make a drug move through a lipophilic barrier is to increase its lipophilicity, it turns out that it is a complex function of all of these characteristics that makes a drug able to pass through the blood-brain barrier. (wikipedia.org)
  • Cosmetic Act
  • Title I of the Drug Quality and Security Act, the Compounding Quality Act, would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. (wikipedia.org)
  • The courts have agreed with the FDA that the Food, Drug, and Cosmetic Act (FDCA) requires information not only on how a product is to be used (e.g., dosage and administration), but also on all the intended uses of the product. (wikipedia.org)
  • bacteria
  • Vanderbilt biochemists have discovered that the process bacteria undergo when they become drug resistant can act as a powerful tool for drug discovery. (phys.org)
  • However, beginning with the first antibiotic treatment for TB in 1943, some strains of the TB bacteria developed resistance to the standard drugs through genetic changes (see mechanisms. (wikipedia.org)
  • The TB bacteria has natural defenses against some drugs, and can acquire drug resistance through genetic mutations. (wikipedia.org)
  • Mutations: Spontaneous mutations in the TB genome can alter proteins which are the target of drugs, making the bacteria drug resistant. (wikipedia.org)
  • Applications discussed range from measurement of slow oxidative degradation of polymers and instability of hazardous industrial chemicals to detection of bacteria in urine and evaluation of the effects of drugs on parasitic worms. (wikipedia.org)
  • physicians
  • Though physicians may prescribe drugs for off-label usage known as off-label marketing, the Food and Drug Administration (FDA) prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved. (wikipedia.org)
  • adverse
  • The principal markets for the Torsion Balances were with the retail druggist who used it in compounding prescriptions, and with users who needed a precision weighing device that could be used under adverse conditions that would quickly ruin balances with knife edges or friction bearings. (wikipedia.org)
  • The bill would require a facility to report biannually to the United States Secretary of Health and Human Services (Secretary) on what drugs are compounded in the facility and to submit adverse event reports. (wikipedia.org)
  • CDI is actively engaged in a number of large-scale iPS cell reprogramming and banking projects, with the goal of creating broadly available resources of iPS cells that represent normal human diversity, disease states and adverse drug reactions. (wikipedia.org)
  • injections
  • For example, three people in Oregon and Washington who died after receiving drugs from Texas - intravenous injections for back pain that were eight times the labeled strength. (pewtrusts.org)
  • In the NECC case, the approved medication for back injections is suspected of being contaminated with fungus during the compounding process. (chicagotribune.com)
  • In April 2012, the FDA received reports of eye infections in patients given injections of Franck's drug products containing triamcinolone during eye surgery. (newsinferno.com)
  • Officials at Franck's previously issued a statement indicating that they conducted a thorough investigation, tracing the contamination to a dye used in ocular triamcinolone injections and formulas containing that drug. (newsinferno.com)
  • patients
  • While many more years of work must be done to test these new compounds in other models and, eventually, in human patients, the work demonstrates a new approach to treating endometriosis and other disorders tied to estrogen signaling and inflammation, the researchers said. (illinois.edu)
  • urges
  • The FDA Commissioner also stated, "In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding. (wikipedia.org)
  • medication
  • The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. (drugs.com)
  • This assumes, of course, that the physician intends that the medication be compounded. (wikipedia.org)
  • illegal
  • The FDA also previously accused Franck's of illegally developing copies of similar drugs, of creating so-called "brews" outside of federal guidelines, and of compounding animal products from drugs not approved for use in the U.S. Franck's was warned in 2005 and, again, in 2009, for illegal animal drug compounding. (newsinferno.com)
  • compounders
  • FDA expects 503A compounders to comply with the current list of drug products that cannot be compounded because they have been withdrawn or removed from the market due to safety or efficacy concerns. (mondaq.com)
  • practice
  • These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. (wikipedia.org)
  • Good Manufacturing Practice (GMP) Violations Off Label Marketing Best Price Fraud CME Fraud Medicaid Price Reporting Manufactured Compound Drugs Involve fraud with the Good Manufacturing Practice (GMP) Regulations which require manufacturers to have adequately equipped manufacturing facilities, adequately trained personnel, stringent control over the manufacturing process, appropriate laboratory controls, complete and accurate records, reports, appropriate finished product examination, and so on. (wikipedia.org)
  • regulation
  • Because thalidomide was never approved for use in the United States, fewer than 50 of those infants were born here.Single-handedly, Kelsey prevented a nationwide tragedy, provided a model for effective government drug regulation and changed the culture and mission of the FDA. (chicagotribune.com)
  • Federal drug regulation demands a delicate balance. (chicagotribune.com)
  • novel
  • A new high-throughput screening technique developed by researchers at the RIKEN Plant Science Center (PSC) has been used to uncover five novel immune-priming compounds in Arabidopsis plants. (phys.org)
  • The novel or designer metabolites produced by fungal endophytes are increasingly recognized by natural chemists due to their diverse structures and as candidates for drug discovery and development. (springer.com)
  • medicines
  • Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. (drugs.com)
  • respectively
  • The new compounds, OBHS (oxabicycloheptene sulfonate) and CLI (chloroindazole), interact with two types of estrogen receptors (ER-alpha and ER-beta, respectively). (illinois.edu)
  • The methodology was successfully applied for two sets of drug compounds, labile at low and high pH, respectively. (diva-portal.org)
  • The company will specifically make their products nifurtimox and suramin, the drugs of choice for the disease respectively, doubly accessible in South America and Africa, where the diseases are prevalent. (wikipedia.org)
  • safety
  • In recent months, this committee has repeatedly stressed the responsibility of FDA to ensure the safety of activities that depart from traditional compounding and are more akin to manufacturing. (pewtrusts.org)
  • CDI began to develop drug compound safety applications early in the company's product development cycle. (wikipedia.org)
  • advances
  • Here we update on the advances made on identifying bioactive metabolites with drug development potential from endophytic fungi. (springer.com)
  • Food
  • That would have happened had it not been for one physician working for the Food and Drug Administration, a brave woman largely forgotten today, named Dr. Frances Kelsey. (chicagotribune.com)
  • Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew's Birmingham metal-on-metal hip implant. (newsinferno.com)
  • products
  • FDA will not enforce the 5 percent cap on the distribution of compounded drug products outside of a 503A compounder's state until FDA finalizes a formal memorandum of understanding (MOU) with the states and allows time for the states' consideration and execution of the MOU. (mondaq.com)
  • Our main emphasis lies on the anti-infective discovery in the view of developing new drug compounds from endophytic products. (springer.com)
  • Title II of the bill, the Drug Supply Chain Security Act (DSCSA), would establish requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. (wikipedia.org)
  • Several published studies have used CDI products to investigate mechanisms of toxicity and have leveraged cellular models to identify toxicity earlier in the drug development process. (wikipedia.org)
  • CDI's products are used in high throughput screens, and have been used as supporting data in Investigational New Drug (IND) submissions to the FDA. (wikipedia.org)
  • CDI's iCell and MyCell products are being used to research the development of regenerative medicine approaches, including: regenerative medicine compound screening, allogeneic and autologous cell therapy, tissue engineering, and transplantation. (wikipedia.org)
  • scientists
  • In the late 1950s, German scientists developed a "wonder drug" for women that was supposed to alleviate the morning sickness, insomnia and headaches of pregnancy. (chicagotribune.com)
  • Scientists at The Scripps Research Institute (TSRI) have invented a set of chemical tools that is radically simplifying the creation of potential new drug compounds. (phys.org)
  • Two new drug compounds - one of which has already proven useful in a mouse model of multiple sclerosis - appear to be effective in treating endometriosis, a disorder that, like MS, is driven by estrogen and inflammation, scientists report in Science Translational Medicine. (illinois.edu)
  • known
  • The chemical compound known as "methylene blue" is a potential candidate for treating Alzheimer's, as it prevents the harmful clumping of so-called tau proteins typically associated with this disease. (phys.org)
  • They began by looking at compounds whose blood-brain permeability was known and labeled them either CNS+ or CNS- for compounds that easily transverse the barrier and those that did not. (wikipedia.org)
  • CJC-1295, also known as DAC:GRF (short for drug affinity complex:growth hormone-releasing factor), is a synthetic analogue of growth hormone-releasing hormone (GHRH) (also known as growth hormone-releasing factor (GRF)) and a growth hormone secretagogue (GHS) which was developed by ConjuChem Biotechnologies. (wikipedia.org)
  • functional
  • Compared to the traditional method, in which chemists modify only the existing functional groups on a compound, CH activation more directly boosts the complexity of a compound, giving it potentially valuable new properties. (medindia.net)
  • we think that we can apply our technique to many compound classes and functional groups. (medindia.net)
  • proteins
  • Another cause of this would be the binding to other proteins in the body rendering the drug ineffective to either be therapeutically active or able to pass through the barrier with the adhered protein. (wikipedia.org)
  • molecular
  • To achieve high efficacy of similarity-based screening of databases containing millions of compounds, molecular structures are usually represented by molecular screens (structural keys) or by fixed-size or variable-size molecular fingerprints. (wikipedia.org)
  • barrier
  • Because of the difficulty for drugs to pass through the blood-brain barrier, a study was conducted to determine the factors that influence a compound's ability to transverse the blood-brain barrier. (wikipedia.org)
  • lipophilicity is not the leading characteristic for a drug to pass through the barrier. (wikipedia.org)
  • They found that there is not a simple answer to what compounds transverse the blood-brain barrier and what does not. (wikipedia.org)
  • The first of these is that a lot of times, even if a compound transverses the barrier, it does not do it in a way that the drug is in a therapeutically relevant concentration. (wikipedia.org)
  • This can have many causes, the most simple being that the way the drug was produced only allows a small amount to pass through the barrier. (wikipedia.org)
  • decrease
  • In order to decrease the amounts owed to states under the Medicaid Drug Rebate Program, some companies misrepresented material facts regarding the regulatory origin/status of their brand name drugs, the AMP, and/or the best price. (wikipedia.org)