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Manufacturers › Risk Mitigation › Pharmaceutical Industry

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

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device...

Arnall Golden Gregory LLP on

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Gabe Scannapieco, AGG Litigation & Dispute Resolution partner, to discuss enforcement trends affecting foreign...more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

Arnall Golden Gregory LLP on

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Arnall Golden Gregory LLP

FDA Tries to Keep Up: FDA Publishes Two New Items Related to Artificial Intelligence

Arnall Golden Gregory LLP on

FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...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

American Conference Institute (ACI)

[Virtual Event] 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - July 21st-22nd, 9:00...

American Conference Institute (ACI) on

Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...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

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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