AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
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 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
On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more
In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more
President Trump’s May 5, 2025, executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” sets out the administration’s goals to increase the domestic manufacture of critical...more
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
The Food and Drug Administration (FDA) is the federal agency charged with ensuring the safety of foods, medications and other consumer products sold in the United States....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
On March 26, 2021, the Food and Drug Administration (FDA) issued a new Federal Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021. As we...more
In last week's Federal Register, the U.S. Food and Drug Administration (FDA) updated and reissued the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2021. This Federal Register Notice announces...more
The FDA has deferred its decision on the biologics license application for MYL-1402O, Mylan and Biocon’s biosimilar to Avastin® (bevacizumab). In a December 25th, 2020 company statement, Biocon cited the FDA’s need for more...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
On Thursday, August 6, 2020 President Trump signed an Executive Order, mandating that certain drugs and medical supplies purchased by federal agencies, including the Department of Health and Human Services, Department of...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
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
• Nearly a month after Hurricane Maria swept through Puerto Rico, roughly 80 percent of the U.S. territory is still without electrical power. • The island is home to multiple drug manufacturing facilities that are directly...more
Case Name: Ranbaxy Labs., Ltd. v. Burwell, 14-cv-1923 BAH, 2015 U.S. Dist. LEXIS 29459 (D.D.C. Mar. 11, 2015) (Howell, J.). Drug Products and Patents-in-Suit: Nexium® (esomeprazole) and Valcyte® (valganciclovir);...more