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Pharmaceutical Industry › Enforcement Authority

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

American Conference Institute (ACI) on

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

American Conference Institute (ACI) on

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

American Conference Institute (ACI) on

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Latham & Watkins LLP

New Guidance on Article 22 EUMR Referrals to the European Commission

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The European Commission (EC) has published new guidance on the application of the referral mechanism set out in Article 22 of the EU merger regulation (EUMR) allowing for mergers falling below national merger thresholds to be...more

Hogan Lovells

FDA extends enforcement discretion period for regenerative medicines, citing COVID-19 challenges

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an additional six months, citing the challenges...more

White & Case LLP

CARES Act Update: Our insights in the first week since enactment

White & Case LLP on

On Friday, March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). The new law provides for $2.2 trillion in emergency aid to ease the financial impact of the COVID-19...more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ Antitrust Division Names New Criminal Deputy Assistant Attorney General

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Richard A. Powers has recently joined the Department of Justice (DOJ) Antitrust Division as the acting deputy assistant attorney general (DAAG) for criminal enforcement and is expected to take on the role permanently. This is...more

Morgan Lewis

2016 Mid-Year Global Cartel Enforcement Report

Morgan Lewis on

Cartel enforcement activity promises to remain busy In the coming months and into 2017 Cartel enforcement remains a priority for competition authorities around the world. Global cartel fines totaled more than $6...more

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