Manufacturers, Pharmaceutical Industry, Risk Mitigation

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

Arnall Golden Gregory LLP on 7/11/2024

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

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

Arnall Golden Gregory LLP on 6/16/2023

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

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

Alston & Bird on 9/22/2020

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

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

American Conference Institute (ACI) on 12/5/2019

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

Legislation Affecting the Pharmaceutical Industry

Farrell Fritz, P.C. on 6/27/2018

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

FDA Issues Draft Guidance on 510(k)

Searcy Denney Scarola Barnhart & Shipley on 8/4/2014

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs.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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