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  • Regulation
  • The Food Security Act of 1985 lists the specific amendments: (1) authorize USDA regulate intrastate, as well as interstate, movement of biological products, (2) broaden the Secretary's authority to issue regulations, (3) enhance enforcement powers, and (4) recognize a congressional view that regulation is "necessary to prevent and eliminate burdens on commerce and to effectively regulate commerce. (wikipedia.org)
  • NCI) Applicable regulatory requirement Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products of the jurisdiction where trial is conducted. (wikipedia.org)
  • This act is related to the regulation of food, drugs, devices, and biological products by the FDA. (wikipedia.org)
  • The FDA Modernization Act of 1997 was a piece of legislation that concentrated on reforming the regulation of food, medical products, and cosmetics in the United States. (wikipedia.org)
  • This law paved the way for further regulation of drug products under the Pure Food and Drug Act of 1906 and the Federal Food, Drug, and Cosmetic Act of 1938. (wikipedia.org)
  • 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  • The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic.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)
  • include
  • 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)
  • 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
  • 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
  • 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)
  • drug products
  • 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)
  • 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)
  • certain
  • Background is the reality that sometimes certain licensed biological products may need to be mixed or diluted in a way not described in the approved labelling for the product to meet the needs of a specific patient. (gmp-compliance.org)
  • While yeast are often more resource-intensive to maintain than bacteria, certain products can only be produced by eukaryotic cells like yeast, necessitating use of a yeast expression platform. (wikipedia.org)
  • 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)
  • 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)
  • animal
  • The Act provides for licensing of products and establishments, and requires permits for the importation of animal biologicals. (wikipedia.org)
  • pharmaceuticals
  • 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)
  • 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)
  • research
  • The Marine Biological Laboratory (MBL) is an international center for research and education in biological and environmental science. (wikipedia.org)
  • Central to its programs are more than 20 Advanced Research Training Courses, graduate-level courses in topics ranging from physiology, embryology, neurobiology, and microbiology to imaging and computation integrated with biological research. (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)
  • system
  • Accordingly, diluting or mixing a biological product with other components, or repackaging a biological product by removing it from its approved container-closure system and transferring it to another container-closure system, is, in the absence of manufacturing controls, highly likely to affect the safety and/or effectiveness of the biological product. (gmp-compliance.org)
  • Each lot is produced within the guidelines of a stringent Quality System to assure consistent product characteristics and performance. (lampire.com)
  • 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)
  • Quality
  • After examining the information available, it was not possible to discern whether MFs have an appreciable effect on supercooling, freezing kinetics, ice crystals, quality, and/or viability of the frozen products. (csic.es)
  • Therefore, more rigorous experimentation and further evidence are needed to confirm or reject the efficacy of MFs in improving the quality of frozen products. (csic.es)
  • Peptides are provided with Mass Spectrometry and HPLC Quality Control data to assure a consistent, reliable product. (lampire.com)
  • solid
  • 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)
  • 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)