• 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)
  • 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)
  • outbreak
  • In New Jersey, where more than a dozen patients died after receiving injections of tainted steroid compound, personal injury attorney Richard P. Console Jr. sees the potential for another serious outbreak. (bio-medicine.org)
  • 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)
  • 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)
  • 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)
  • 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)
  • From the group of 290 compounds, the scientists identified 27 that, in test tube experiments, showed activity against both MERS-CoV and the related SARS coronavirus. (innovations-report.com)
  • medicines
  • Representatives Rosa DeLauro and Edward Markey said in separate statements that they will draft legislation to give the Food and Drug Administration more authority to police the safety of custom-mixed medicines, known as compounded drugs. (journalgazette.net)
  • Recall
  • It's time to recall the heroism of the woman who saved the nation from a medical disaster a half century ago by paying attention to the importance of drug testing and oversight, Dr. Frances Kelsey. (chicagotribune.com)
  • chemical compound
  • 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)
  • Chemical semantic similarity measures has shown to be a feasible and effective approach to improve existing chemical compound classification systems. (wikipedia.org)
  • risks
  • Dirty Drugs and We Know It: Attorneys at Console & Hollawell Comment on ISMP Survey Relating to Contaminated Drug Compounds and the Risks to. (bio-medicine.org)
  • Without knowing where the drugs have come from, what their quality is, or even what kind of drugs are being injected, there can be no assurances that the drugs will work - and the prisoner risks dying in agony. (reprieve.org.uk)
  • 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)
  • These compounds have a net positive charge that is electrostatically attracted to the negative-charged cell membranes of certain viruses, fungi and bacteria. (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)
  • 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)
  • 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)
  • amino
  • The team used the technique to quickly modify a variety of compounds, including the amino acid phenylalanine and the neurotransmitter-mimicking drug baclofen. (medindia.net)
  • Ceragenins, or cationic steroid antimicrobials (CSAs), are synthetically-produced, small-molecule chemical compounds consisting of a sterol backbone with amino acids and other chemical groups attached to them. (wikipedia.org)
  • Cosmetic Act
  • 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)
  • inactivate
  • On February 6, 2006, researchers (including Dr. Paul B. Savage) announced that a Ceragenin compound, CSA-54, appears to inactivate HIV. (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)
  • 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)
  • CDI began to develop drug compound safety applications early in the company's product development cycle. (wikipedia.org)
  • mass
  • Compounding errors can cause exponentially greater harms if the product has been produced in mass quantities. (pewtrusts.org)
  • Among the greatest concerns of the FDA regarding compounded products is compounding intended to circumvent the drug approval process, resulting in mass marketing of products that have had little or no quality control to ensure purity, potency, and stability. (merckvetmanual.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)
  • Since the decision, the FDA has generally only gotten involved in compounding drug cases that involved large numbers of products distributed across state lines. (journalgazette.net)
  • Given development times and manufacturing requirements for new products, repurposing of existing drugs is likely the only solution for outbreaks due to emerging viruses," the investigators noted in the paper now online in the journal Antimicrobial Agents and Chemotherapy . (innovations-report.com)
  • 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)
  • 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)
  • specifically
  • Clinicians treating patients suffering from Middle East respiratory syndrome (MERS) currently have no drugs specifically targeted to the MERS coronavirus (MERS-CoV), a virus first detected in humans in 2012 that has since caused 614 laboratory-confirmed infections, including 181 that were fatal, according to the World Health Organization. (innovations-report.com)
  • involve
  • For food animals, in the absence of a drug labeled for the intended use, extra-label drug use might involve drugs approved for use in other food animals, approved for use in nonfood animals, or approved for use in people. (merckvetmanual.com)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • made
  • Unfortunately, dermatologic surgeons are familiar to the issue of patient fatality due to poorly made compounded drugs. (cnbc.com)
  • Calcium balance studies External counting method Formal kinetic analysis Through these studies, major conclusions were made regarding the drug compound. (wikipedia.org)
  • 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)
  • ASDSA President-Elect Mitchel P. Goldman, M.D., testified before the U.S. Food and Drug Administration (FDA) in 2004 about a study he conducted with similar results. (cnbc.com)
  • Most restrictions are largely applicable to extra-label drug use in food animals. (merckvetmanual.com)
  • To address the urgent need for therapies, researchers supported by the National Institutes of Health screened a set of 290 compounds already approved by the U.S. Food and Drug Administration or far advanced in clinical development for other indications to determine if any might also show potential for working against MERS-CoV. (innovations-report.com)
  • different
  • 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)
  • Almost two-thirds of the natural antimicrobial drug compounds used currently are produced by different species of Actinomycetes. (wikipedia.org)
  • jurisdiction
  • 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)
  • potentially
  • 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)
  • 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)
  • state
  • In Dr. Flynn's home state of North Carolina, a young woman fell into a coma and died in 2005 when she used a large amount of compounded numbing agent prior to laser hair removal. (cnbc.com)
  • In October 2012, an investigation of the NECC revealed the company had been in violation of its state license because it had been functioning as a drug manufacturer, producing drugs for broad use rather than filling individual prescriptions. (wikipedia.org)
  • known
  • 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)
  • large
  • Cellular Dynamics International (CDI) is a large scale manufacturer of human cells, created from induced pluripotent stem cells, for use in basic research, drug discovery and regenerative medicine applications. (wikipedia.org)
  • The concept of chemical similarity can be expanded to consider chemical similarity network theory, where descriptive network properties and graph theory can be applied to analyze large chemical space, estimate chemical diversity and predict drug target. (wikipedia.org)