Regulatory Watch

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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meetings to discuss “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption: Draft Guidance for Industry.”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 announced an in-person meeting of the National Organic Standards Board (NOSB).

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The FDA has announced the availability of draft guidance entitled “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving-Size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.”

The USDA's Animal and Plant Health Inspection Service has announced a correction to the economic analysis presented in the final rule amending regulations governing the importation and interstate movement of fruits and vegetables.

The FDA is eliminating the use of styrene as a flavoring substance and adjuvant for use in food.

The USDA’s Agricultural Marketing Services (AMS) has proposed a decrease in the assessment rate for oranges and grapefruit grown in the Lower Rio Grande Valley in Texas.