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Home » Topics » Regulatory Watch

Regulatory Watch
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Regulatory Watch

Amending the definition of the term "biological product"

Sharon Spielman
Sharon Spielman
February 12, 2019
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."
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Regulatory Watch

FDA withdraws proposed rule on labeling for approved drugs, biological products

Sharon Spielman
Sharon Spielman
February 12, 2019
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.
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Regulatory Watch

FDA announces meetings for draft guidance for produce

Sharon Spielman
Sharon Spielman
January 18, 2019
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meetings to discuss “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption: Draft Guidance for Industry.”
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Regulatory Watch

USDA announces NOSB meeting

Sharon Spielman
Sharon Spielman
January 18, 2019
The USDA's Agricultural Marketing Service (AMS) has announced an in-person meeting of the National Organic Standards Board (NOSB).
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Regulatory Watch

USDA final rule amends the handling of California raisins

Sharon Spielman
Sharon Spielman
December 17, 2018
The USDA's Agricultural Marketing Service (AMS) has amended the Marketing Order that regulates the handling of raisins produced from grapes grown in California.
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Regulatory Watch

FDA announces draft guidance on food labeling

Sharon Spielman
Sharon Spielman
December 17, 2018
The FDA has announced the availability of draft guidance entitled “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving-Size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.”
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Regulatory Watch

APHIS corrects economic analysis of final rule for fruits and vegetables

Casey Laughman
Casey Laughman
November 21, 2018
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.
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Regulatory Watch

FDA amends additive regulations to eliminate styrene

Casey Laughman
Casey Laughman
November 21, 2018
The FDA is eliminating the use of styrene as a flavoring substance and adjuvant for use in food.
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Regulatory Watch

Agricultural Marketing Services proposes decrease in Texas citrus assessment rate

Casey Laughman
Casey Laughman
October 12, 2018
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.
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Regulatory Watch

FDA announces draft guidance on food facility registration

Casey Laughman
Casey Laughman
October 12, 2018
The FDA has announced the availability of draft guidance for industry entitled “Supplemental Questions and Answers Regarding Food Facility Registration.”
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