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Supply Chain Food and Drug Administration (FDA) New Regulations

BakerHostetler

FDA’s ‘PreCheck’ Program: New Pathway to Acceleration of US Drug Manufacturing

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. ...more

Hogan Lovells

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

Hogan Lovells on

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more

ArentFox Schiff

Biden's Executive Order Focusing on Biotechnology Offers Opportunities for AgTech Industry

ArentFox Schiff on

President Biden has revealed the next areas of focus in his effort to protect the United States’ technological leadership and economic competitiveness: biotechnology, biomanufacturing, and the bioeconomy....more

American Conference Institute (ACI)

[Event] Controlled Substances – Regulation, Litigation, and Enforcement - July 12th - 13th, Washington, DC

The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...more

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

Faegre Drinker Biddle & Reath LLP

Long-Awaited FSMA Final Rules Published

On September 10, 2015, the U.S. Food and Drug Administration (FDA) made public two final Food Safety Modernization Act (FSMA) rules: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls...more

Womble Bond Dickinson

FDA Gives Food Industry Three Years to Phase Out Partially Hydrogenated Oils from Food Products

Womble Bond Dickinson on

On June 16, 2015, the Food and Drug Administration ("FDA") issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils ("PHOs"). In its order, the FDA stated that partially hydrogenated oils...more

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