Fierce Pharma

FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program

The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit ...
PharmTech

FDA Launches PreCheck Pilot Program to Bolster Domestic Drug Manufacturing

FDA Commissioner Marty Makary, M.D., M.P.H., characterized the program as a “bold step” to bring manufacturing back to the US and make the domestic sector more resilient and competitive. This program ...
BioPharma Dive

FDA launches ‘PreCheck’ program; AstraZeneca, Acadia drugs set back

The agency’s program will be open to pharmaceutical facilities that align with “national priorities.” Elsewhere, a self-administered lupus drug was turned back and MeiraGTx picked up another gene ...
JD Supra

FDA Updates Food Labeling Compliance Program: What It Means for Food Manufacturers

In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This ...
JD Supra

FDA Releases Human Foods Program (HFP) 2026 Priority Deliverables

The U.S. Food and Drug Administration (FDA) Human Foods Program (HFP) published its 2026 Priority Deliverables, outlining a ...
PharmExec

Pharmaceutical Executive Daily: FDA Reveals PreCheck Pilot Program

In today’s Pharmaceutical Executive Daily, the FDA introduces a PreCheck pilot program aimed at strengthening domestic manufacturing oversight, an ACIP member alleges FDA leadership halted a decision ...