News & Analysis as of

Medical Devices Risk Assessment Prescription Drugs

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

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

ArentFox Schiff

FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics

ArentFox Schiff on

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Announces That Domestic Inspections Will Resume

On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more

Smart & Biggar

Rx IP Update - February 2019

Smart & Biggar on

Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...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

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FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs.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