The FDA has proposed to amend its regulation that defines "biological product" to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), and to provide its interpretation of the statutory terms "protein" and "chemically synthesized polypeptide."
The FDA has announced the withdrawal of the proposed rule on "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products," published in the Federal Register of Nov. 13, 2013.
The FDA will hold four public meetings to discuss “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption: Draft Guidance for Industry.”
The USDA's Agricultural Marketing Service (AMS) has amended the Marketing Order that regulates the handling of raisins produced from grapes grown in California.
The FDA has announced the availability of draft guidance entitled “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving-Size Related Issues, Dual Column Labeling and Miscellaneous Topics.”
Though Cyclospora outbreaks in the US happen less frequently than those caused by typical pathogens, the recent salad mix outbreaks occurring in July and August of this year have a familiar ring.
The FDA has announced the availability of draft guidance for industry entitled “Supplemental Questions and Answers Regarding Food Facility Registration.”
Effective Oct. 9, 2018, the FDA has amended its food additive regulations to no longer allow for the use of a total of seven synthetic flavoring substances and flavor enhancers (adjuvants)—six due to health concerns, and one additional flavor that is being delisted because it’s no longer used by industry.
