Topic
Drug Manufacturing
64 published works
Faeger Drinker on Products
California Supreme Court Rejects Duty to Innovate
On August 3, 2026, the California Supreme Court issued its decision in the closely watched Gilead Tenofovir Cases, No. S283862, — Cal.5th —, 2026 WL 2223748 (Cal. Aug. 3, 2026),…
Agricultural Law & Rural Practice | Solo Small Firm & General Practice Section
FDA Proposes Distributed Manufacturing Registration Pathway and Aligns Foreign Establishment Registration and Listing Requirements With Current Law
By Hall Render
The U.S. Food and Drug Administration (“FDA”) issued a proposed rule to update drug establishment registration and listing requirements for distributed manufacturing (“DM”) and certain foreign drug establishments. If finalized,…
As Prescribed
FDA’s Warning Letter Suggests Growing Scrutiny of AI Overreliance
By Morgan Lewis
A recently issued Food and Drug Administration (FDA) Warning Letter citing a drug manufacturer for improper use of artificial intelligence (AI) suggests FDA’s scrutiny of AI is expanding. Although not…
Regulatory Oversight
Texas AG Secures $41.5M Settlement With Pfizer and Tris Pharma Over Allegedly Adulterated ADHD Drug: What Health Care Stakeholders Should Know
By Troutman Pepper Locke State Attorneys General Team
The Texas attorney general (AG) announced a $41.5 million settlement with Pfizer and Tris Pharma related to allegations that the companies provided adulterated pharmaceutical products to children and manipulated testing…
GoodLifeSci
FDA Launches “PreCheck” Program to Support U.S. Pharmaceutical Manufacturing: What Industry Stakeholders Should Know
By James R. Johnson, Christopher A. Fanelli, Michael Varrone, Mia R. Harris
On August 7, 2025, the U.S. Food and Drug Administration (FDA) announced FDA PreCheck, a new two-phase framework aimed at bolstering the domestic pharmaceutical supply chain by streamlining the regulatory process…
Government Contracts Navigator
Domestic Production of Pharmaceuticals: Are the Administration’s Efforts Enough?
Merle M. DeLancey, Jr. ● The Administration issued Executive Order (“EO”) 14293: Regulatory Relief to Promote Domestic Production of Critical Medicines on May 5, 2025 (whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines). The EO seeks to ease…
The Daily Intake
FDA Lessens Hurdles for Color Additive Changes in Drugs
On May 30, 2025, FDA issued a draft guidance titled “Replacing Color Additives in Approved or Marketed Drug Products.” Neither the draft guidance nor FDA’s Federal Register notice announcing its…
Health Industry Washington Watch
Trump Executive Orders seek to encourage reshoring of pharmaceutical manufacturing and research
By Vicki Tankle, Sarah Thompson Schick, Matthew Loughran
On May 5, the Trump Administration issued a pair of executive orders that could signal big changes for the drug industry and health research efforts in the United States. The…
Health Care and Life Sciences
Onshoring Pharma Ops: Reading Recent EO and Policy Tea Leaves
By Dominick DiSabatino, Jonathan Wang, Julian Klein
This week, underscoring a commitment to national security, the White House and the Food and Drug Administration (FDA) issued separate communications that aim to bolster domestic drug manufacturing while tightening…
Government Contracts Navigator
Biden Administration Prioritizing Domestic Production of Pharmaceuticals . . . Again?
Merle M. DeLancey, Jr. ● On November 27, the Administration announced another blue-ribbon panel to bolster the domestic manufacturing of pharmaceuticals. This one is called the Supply Chain Resilience Council. Co-chairs…