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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)
  • medicinal product
  • NCI) Adverse drug reaction In the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. (wikipedia.org)
  • The phrase "responses to a medicinal product" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. (wikipedia.org)
  • EMA/286914/2012: Multiplicity issues in clinical trials (EMA) addresses the multiplicity in the clinical trials in the context of an application for marketing authorisation of a medicinal product. (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
  • This may include concentrating the product, formulation revision (i.e., addition of components to increase stability, preserve appearance, and/or improve processing), decreasing a high-vapor-pressure solvent, or increasing the surface area. (wikipedia.org)
  • 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)
  • crystals
  • 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)
  • 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)
  • To produce larger crystals, the product should be frozen slowly or can be cycled up and down in temperature. (wikipedia.org)
  • frozen
  • 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)
  • 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)
  • 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)
  • application
  • The Healthcare Reform Law provides only for one reference product per application. (morganlewis.com)
  • Within this draft document, FDA shows their policy regarding the mixing, diluting, and repackaging of certain types of biological products that have been licensed under section 351 of the Public Health Service Act (PHS Act) when such activities are not within the scope of the product's approved biologics license application (BLA) as described in the approved labelling for the product. (gmp-compliance.org)
  • and reduce the need for environmental assessment as part of a product application. (wikipedia.org)
  • secondary
  • Amorphous materials do not have a eutectic point, but they do have a critical point, below which the product must be maintained to prevent melt-back or collapse during primary and secondary drying. (wikipedia.org)
  • medical
  • NCI) An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. (wikipedia.org)
  • company
  • The area provides many suppliers the company needs, such as farm equipment, feed in bulk amounts and other agriculture-related products. (lampire.com)
  • The company was founded by Dr. D.V.K. Raju and Mr. G.A.N. Raju in 1953 as Biological Products Private Limited. (wikipedia.org)
  • The company started manufacturing its flagship vaccine product, Pentavalent (DTP Hib HepB) in 2008. (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)
  • animal
  • The Act provides for licensing of products and establishments, and requires permits for the importation of animal biologicals. (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)
  • 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)
  • produce
  • 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)
  • This board was given the power to issue, suspend, and revoke licenses to produce and sell biological products. (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)
  • 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)
  • 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)
  • Quality
  • Peptides are provided with Mass Spectrometry and HPLC Quality Control data to assure a consistent, reliable product. (lampire.com)
  • Each lot is produced within the guidelines of a stringent Quality System to assure consistent product characteristics and performance. (lampire.com)
  • In many instances the decision to pretreat a product is based on theoretical knowledge of freeze-drying and its requirements, or is demanded by cycle time or product quality considerations. (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)
  • 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)