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Pharmaceutical Industry › Risk Assessment › Manufacturers

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

Ropes & Gray LLP on

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

Arnall Golden Gregory LLP

[Webinar] Mitigating the Impact of Tariffs: A Practical Guide for Life Sciences Companies - June 17th, 12:00 pm - 1:00 pm EDT

Arnall Golden Gregory LLP on

AGG partner and Life Science team member, Allison Raley, will present a complimentary webinar examining how life sciences companies can overcome challenges in the face of U.S. tariffs. As international trade tensions persist...more

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

Baker Donelson on

What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

Butler Snow LLP on

Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

Alston & Bird

Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110

Alston & Bird on

Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more

King & Spalding

FDA Alerts Pharmaceutical Manufacturers to Risk of Benzene in Certain Drugs

King & Spalding on

FDA Continues to Focus on Identifying and Controlling Trace Impurities in Drugs - On December 23, 2021, the U.S. Food and Drug Administration (“FDA”) alerted drug manufacturers that FDA was investigating the root cause of...more

Alston & Bird

FDA Issues New Guidance on Nitrosamine Impurities in APIs and Drug Products

Alston & Bird on

Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and what manufacturers can do...more

Farrell Fritz, P.C.

Legislation Affecting the Pharmaceutical Industry

Farrell Fritz, P.C. on

During a year in which legislative activity was restrained by a variety of factors, most notably the Senate’s inability to maintain a consistent majority, the New York State Legislature nonetheless still passed 641 bills,...more

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Thomas Fox - Compliance Evangelist on

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

Searcy Denney Scarola Barnhart & Shipley

FDA Issues Draft Guidance on 510(k)

Searcy Denney Scarola Barnhart & Shipley on

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

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