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

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.

BayBiotech.NET The Hazardous Waste Source Reduction and Management Review Act of 1989 applies to large quantity generators that produce more than 12,000 kilograms (13.2 tons) of hazardous waste, or 12 kilograms (26 pounds) of extremely hazardous waste, in 1990 and every four years thereafter. The law requires the generator companies of such hazardous waste to: • Conduct a source reduction evaluation of their facilities and prepare the following:  Source Reduction Evaluation Review and Plan (Plan)  Hazardous Waste Management Performance Report (Report)  Summary Progress Report (SPR) • Implement feasible methods for reducing the quantity and/or the hazardous characteristics of routinely generated hazardous waste. The main purpose of requiring generators to review and implement source reduction practices is to reduce the quantity of hazardous waste generated in California and thereby to promote public health and safety and to improve environmental quality. Such a source

BayBiotech.NET On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of