Loading...

Warning: preg_replace(): Compilation failed: missing ) at offset 18 in /home/lookformedical/www/faq.php on line 186
  • tissues
  • The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) on Wednesday released its annual summary of manufacturing deviations reported by biologics, blood and blood component, and human cells, tissues, and cellular and tissue-based products (HCT/P) manufacturers. (raps.org)
  • If all these advantages were true, magnetic freezing would represent a significant advance in freezing technology, not only for food preservation, but also for cryopreservation of biological specimens such as cells, tissues, and organs. (csic.es)
  • Founded in 1977, the Pennsylvania based company offers an extensive line of secondary antibodies, purified IgGs, human and animal blood products, plus a comprehensive line of animal tissues and organs. (lampire.com)
  • gene therapy
  • The European Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering", including gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines, and combinations thereof. (wikipedia.org)
  • With the development of biotechnology, the FDA's Center for Biologics Evaluation and Research (CBER) has taken a larger role in reviewing and approving new biological products intended for medical purposes, including probiotics, xenotransplantation and gene therapy. (wikipedia.org)
  • guidance
  • The Healthcare Reform Law does not require FDA to issue a guidance document to articulate the policies for each product class, and the nonissuance of guidance does not preclude approval of a biosimilar. (morganlewis.com)
  • Importantly, FDA may indicate in a guidance document that the "science and experience" for a product or product class does not allow approval through the biosimilar framework. (morganlewis.com)
  • The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic. (raps.org)
  • An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). (wikipedia.org)
  • drug products
  • For information concerning human drug products: Audrey A. Thomas, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5625. (fda.gov)
  • Pharmacy Compounding The act creates a special exemption to ensure continued availability of compounded drug products prepared by pharmacists to provide patients with individualized therapies not available commercially. (wikipedia.org)
  • regulatory
  • The UK's Medicines and Healthcare products Regulatory Agency (MHRA) found Apotex Research Private Limited's Bangalore, India-based manufacturing site to be noncompliant. (raps.org)
  • Name
  • The Biological Products Industry Alliance (BPIA), formerly the BioPesticide Industry Alliance, is the new name of the rapidly growing U.S.-based trade association representing the biological products industry. (croplife.com)
  • Changing our name was an important next step toward being more inclusive of a broader range of science-based biological products that create value in North America and around the world. (croplife.com)
  • The Biologics Control Act also mandated that all products be labeled accurately with the name of the product and the address and license number of the manufacturer. (wikipedia.org)
  • Food
  • For information concerning human biological products: Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-594-3074. (fda.gov)
  • What's less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market. (raps.org)
  • According to advertisements, magnetic freezing is able to generate tiny ice crystals throughout the frozen product, prevent cell destruction, and preserve the quality of fresh food intact after thawing. (csic.es)
  • range
  • Disclosed is a process of selecting of a container and temperature-control system, such that biological products (including blood) requiring maintenance within a specified range of temperatures are so maintained during shipment. (google.com.au)
  • 4. The process of claim 1 wherein the database is established by deriving, from the characteristics of the containers and the phase change material, the length of time each member system can maintain products housed in the containers with the phase change material within a specified range of temperatures when the member system is exposed to specified ranges of ambient temperatures for specified time periods. (google.com.au)
  • As indicated the term "biologics" can be used to refer to a wide range of biological products in medicine. (wikipedia.org)
  • Like many esters, it is found in a range of fruits and biological products. (wikipedia.org)
  • human
  • In general a microorganism used as an expression platform has to meet several criteria: it should be able grow rapidly in large containers, produce proteins in an efficient way (i.e. with minimal resource input), be safe and, in case of pharmaceuticals, it should produce and modify the products to be as ready for human consumption as possible. (wikipedia.org)
  • include
  • The latest product releases include New Zealand sourced animal blood products, the gas-permeable LAMPIREĀ® Cell Culture Bag and exclusive antibodies to chemotherapeutic agents. (lampire.com)
  • Common platforms for the development of medicine and other products include the bacterium E. coli, and several yeasts and mammalian cells (including, notably, Chinese hamster ovary cells). (wikipedia.org)
  • industry
  • Typically in solid, semi-solid or liquid state, it is in fact an amalgamation of all the liquid wastes that are discharged by domestic houses, commercial properties, industry, and/or agriculture after aerobic biological treatment. (environmental-expert.com)
  • BPIA's goal is to be the single voice for the entire biological products industry," said Rick Melnick, Chair of the BPIA Board of Directors and Global Brand Manager for Valent BioSciences Corporation. (croplife.com)
  • means
  • The term "interchangeable" or "interchangeability" means that the biological product may be substituted for the reference product without the intervention of the healthcare provider that prescribed the reference product. (morganlewis.com)
  • In addition, the specification of no clinically meaningful differences relative to the reference biologic means that FDA will need to develop policies for each product class, because of the differences in potential safety issues for different biologics. (morganlewis.com)
  • subject
  • It is required that every person who is trained to prepare biological products subject to the VSTA shall have an unexpired, unsuspended, and unrevoked U.S. Veterinary Biologics Establishment License and at least one unexpired, unsuspended, and unrevoked U.S. Veterinary Biological Product License issued by the Administrator to prepare a biological product. (wikipedia.org)
  • provide
  • The act also allows drug companies to provide economic information about their products to formulary committees, managed care organizations, and similar large-scale buyers of health-care products. (wikipedia.org)
  • single
  • Removing a biological product from the original container at the point of care for immediate administration to a single patient after receipt of a patient-specific prescription or order for that patient (e.g., drawing up a syringe to administer directly to the patient). (gmp-compliance.org)
  • patients
  • For example, if there is no licensed pediatric strength and/or dosage form for the product defined and licensed, it must be diluted for use in pediatric patients. (gmp-compliance.org)
  • animal
  • The Act provides for licensing of products and establishments, and requires permits for the importation of animal biologicals. (wikipedia.org)
  • prescription
  • Upon receipt of a patient-specific prescription, a licensed pharmacy removing from one container the quantity of solid oral dosage form biological products necessary to fill the prescription and placing it in a smaller container to dispense directly to its customer. (gmp-compliance.org)
  • treatment
  • This factor has been particularly relevant since many biological medications are used for the treatment of chronic diseases, such as rheumatoid arthritis or inflammatory bowel disease, or for the treatment of otherwise untreatable cancer during the remainder of life. (wikipedia.org)
  • articles
  • The act allows a firm to circulate peer-reviewed journal articles about an off-label indication of its product, providing the company is also committing itself to file proof of research within a certain amount of time. (wikipedia.org)
  • purposes
  • A license will not be issued unless the Administrator feels the establishment will use the products efficiently for all its intended purposes. (wikipedia.org)