Life is a Journey..how to make the best of it!

BayBiotech.NET US government has faced challenges in producing medical countermeasures for emerging infectious diseases, pandemics, and bioterrorism that carry the potential for catastrophic impact. President called out the renewed need for a national capability to respond to these threats in the State of the Union, and the Secretary of HHS stepped forward to address this need with new strategies that envision a capabilities-based approach with an active role by the U.S. government in forging partnerships, modernizing regulatory oversight, and supporting transformative technologies. To read about the Medical countermeasure strategies click here .

Although cosmetic companies are not subject to mandatory establishment registration or ingredient reporting but they may voluntarily register their establishments and their product compositions through FDA’s Voluntary Cosmetic Registration Program (VCRP). Data provided by Cosmetic Companies through the VCRP helps the agency to prioritize its safety testing program. Anyone can have access to the information registered with VCRP through the Freedom of Information Act. Registration with VCRP also enables agency to notify cosmetics companies about potential problems with the ingredients in their products and helps the agency with inspections that may be necessary. However, registration with VCRP is prohibited from being used as a promotional tool. Reference: Fundamentals of US Regulatory Affairs, Sixth Edition.

Patient Protection and Affordable Care Act (PPAC Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act to create an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to or “interchangeable” with an FDA-approved biological product. These new provisions may also be referred to as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The goal of the BPCI Act is similar, in concept, to that of the Drug Price Competition and Patent Term Restoration Act of 1984 (a.k.a the “Hatch-Waxman Act”) which created abbreviated pathways for the approval of drug products under Federal Food, Drug, and Cosmetic Act (FFD&C Act). The BPCI Act aligns with the FDA’s longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing. To read more about this,

FDA has very limited authority to regulate food before it goes on the market. A significant exception is regulation of food and color additives, which must be approved by FDA as safe for intended uses prior to marketing. Definition of “food additive” includes not just the ingredients added to the food, but also any substance used in the production process that could end up in the food, including packaging material that could leach onto food and lubricants on the machines that touches the food during processing. FD&C Act specifically excludes the following types of substances from the definition of food additives: Any substance that is generally recognized as safe for its intended uses by scientific experts. Pesticide chemical residues. Pesticides. Color additives. New animal drugs. New dietary ingredients. Prior sanction: any substance approved or sanctioned for use prior to 6 September, 1958 under the FD&C Act of 1906 or the Poultry Products Inspection Act of 1

I would like to share that on Tuesday, June 29th, Medpedia announced RareSpace, an online knowledge sharing platform for rare childhood diseases, which affect 22.5 million American families. Designed in partnership with the R.A.R.E. Project and the Children’s Rare Disease Network, RareSpace provides a platform to advance research and share information on these diseases. Parents, physicians, researchers, advocates and others interested in rare diseases are encouraged to participate in discussions and share information about genetic diseases, innovations in research, and standards of care. Medical professionals in RareSpace will answer questions about treatment, best practices, and how to best help these children and their families. Anyone with an interest in rare diseases is invited to join at http://www.medpedia.com/communities/274-RareSpace .

As per 21 CFR 864. 4020(a), ASRs are defined as antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASRs are medical devices that are regulated by FDA. They are subject to general controls, including current Good Manufacturing Practices (cGMPs), 21 CFR Part 820, as well as the specific provisions of the ASR regulations (21 CFR 809.10(e), 809.30, 864.4020). The guidelines set by FDA for marketing the ASRs are known as “The ASR Rules”. The rule classifies most ASRs as Class I devices subject to general controls under section 513(a)(1)(A) of the Act, but exempt from premarket notification. To read more about the ASR Rule, follow the link .

Pediatric Research Equity Act (Dec, 2003) requires pediatric studies of certain drugs and biological products unless waived or deferred. The law mandates a pediatric assessment for applications with new ingredients, new indications, new dosage forms, new dosing regimens or new routes administration. PREA also requires that the studies must be designed to pose minimal risks and direct benefit. For a course of disease or effect similar to adults, effects can be extrapolated from the studies conducted in adults. To read more about the PREA, click here.