Clinical Operations-Design to Execution

BayBiotech.NET The recently passed Food Safety bill is being considered to be a major overhaul of the food safety system in the United States and is considered to change the mission of the FDA, focusing it on preventing food-borne illnesses rather than reacting after an outbreak occurs. Under this legislation, food manufacturers are required to examine their processing systems to identify possible ways that food products can become contaminated and to develop detailed plans to keep that from happening. Companies must share those plans with the F.D.A., and provide the agency with records, including product test results, showing how effectively they carry them out. To read more about it follow the link

BayBiotech.NET A good read on Personalized Medicine: http://www.nigms.nih.gov/Initiatives/PGRN/Background/FactSheet.htm

BayBiotech.NET Visit the new FDA page at: www.facebook.com/fda.The page will provide regular updates on FDA news and events as well as Federal health and safety information of interest to the public. Also, FDA is taking its public health message to Flickr. Visit FDA on Flickr at: www.flickr.com/photos/fdaphotos/.

BayBiotech.NET Legal export provisions become applicable only when a device has not been approved or cleared for domestic marketing. Except 21CFR 812.18, no regulations have been codified to establish how the export of unapproved devices must be managed. An unapproved deivce must meet the following criteria in order to qualify the for legal export: 1. meet the foreign purchaser's specifications 2. not be in conflict with the importing country's laws 3. be labeled," intended for export only" on the outside of the shipping package 4. not be sold or offered for sale in domestic commerce Reference: Fundamentals of US Regulatory Affairs, Sixth Edition (Regulatory Affairs Professional Society).

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, ...