Decoding the Key Management Personnel Requirements
What to Do if Your Suppliers Are in Distress - Candid Conversations with Suppliers in Distress
The Labor Law Insider: Union Activity, Employment Engagement, and Changes in the Manufacturing Industry, Part II
The Labor Law Insider: Union Activity, Employment Engagement, and Changes in the Manufacturing Industry
Stoel Rives | Deeply Rooted Podcast S2E5: Jeffrey Chang, President of FPS Food Process Solutions, On Starting a Commercial Manufacturing Business as an Immigrant and the Opportunities for the Industry
Five Questions, Five Answers: Driving the I-75 with Rick Walker of GAMA Georgia
Williams Mullen Manufacturing Edge: Environmental Enforcement in the Current Regulatory Climate
Making Trade Inclusive for All Americans Podcast: A Conversation with the President of the Steel Manufacturers Association (SMA)
The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others. On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more
On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). CPGs are intended to advise FDA staff as to the agency's strategy when assessing and...more
On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The...more
Key Takeaways - The COVID-19 pandemic led the U.S. Food and Drug Administration (FDA) to pause most foreign and domestic inspections and begin conducting remote interactive evaluations. FDA has since issued a written policy...more
Preparation is key in surviving an EPA or state environmental agency inspection. Your facility may have advance warning that the inspector will be visiting, so the disruption caused by the inspection can be minimized, but...more
The Food and Drug Administration is the federal agency charged with ensuring the safety of food, medication and other consumable products. In carrying out its duties, the FDA conducts both inspections of plants and...more
As we reported at the beginning of the year, President Biden has been making environmental justice one of his priorities since long before he took office. The United States Environmental Protection Agency (EPA) recently took...more
Over the past year and as a result of the COVID-19 pandemic, FDA relied on alternative inspectional tools and approaches, including remote interactive evaluations and record requests, as well as a prioritization scheme, to...more
On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public...more
In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more
Revance Therapeutics, Inc. recently announced that, because of COVID-19 travel restrictions, the FDA has been unable to complete its inspection of the manufacturing facility for Revance’s DaxibotulinumtoxinA for Injection...more
The U.S. Food and Drug Administration (FDA) recently provided an update regarding its plans for conducting routine surveillance inspections of domestic and foreign facilities during the COVID-19 pandemic. FDA announced in...more
In an unprecedented time amid the global COVID-19 pandemic, an increasing number of pharmaceutical manufacturers and developers of active pharmaceutical ingredients are involved in the potentially life-saving development of...more
U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak. Manufacturers, including contract...more
Seyfarth Synopsis: OSHA recently updated its National Emphasis Program on Amputations in Manufacturing Industries (NEP), adding a targeting methodology for industries with high employer-reported amputation statistics....more
Introduction: CGMPs and FDA Inspections - Current Good Manufacturing Practices (CGMPs) are mandated by regulations enforced by the U.S. Food and Drug Administration (FDA), and must be implemented and followed by...more