The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
5/29/2024
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Canada ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
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Manufacturers ,
Pharmaceutical Industry ,
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Prescription Drugs ,
Supply Chain
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more
The United States Department of Agriculture ("USDA") published the Strengthening Organic Enforcement ("SOE") Final Rule to improve farm-to-market traceability, deter and detect instances of organic fraud, increase oversight,...more
On November 7, 2022, the U.S. Food and Drug Administration ("FDA") sent the Food Safety Modernization Act ("FSMA") Final Rule on Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal...more
Top News -
FDA Announces Intention to Not Enforce Certain FSMA Final Rules Provisions -
On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce...more
1/16/2018
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Animal Food ,
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ECHA ,
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European Food Safety Authority (EFSA) ,
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Wetlands