News & Analysis as of

Food and Drug Administration (FDA) › Administrative Proceedings

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2020 Decisions: Amneal Pharm. LLC v. Almirall, LLC, 960 F.3d 1368...

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

Abbreviated new drug (ANDA) applicant Amneal petitioned for an inter partes review (IPR) of Almirall’s patent listed in the Food and Drug Administration’s (FDA) Orange Book for a prescription drug to treat acne. Almirall...more

Polsinelli

What COVID-19 Means for FDA-Regulated Industry

Polsinelli on

U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Final Guidance on Citizen Petitions and Stay of Action Petitions Subject to FDCA Section 505(q)

Wilson Sonsini Goodrich & Rosati on

Introduction: Citizen Petitions in the News - Citizen petitions and stay of action petitions (collectively, citizen petitions or petitions) are in the news. Formally, citizen petitions are a mechanism for "interested...more

Harris Beach PLLC

Doe v. Merck: Vaccine Autism Lawsuit Dismissed as Baseless

Harris Beach PLLC on

The claim that the MMR vaccine caused autism was meritless on its face, held the U.S.D.C., Eastern District of New York (Doe v. Merck & Co, Inc.). The action filed on behalf of “Baby Doe” stemmed from Merck-manufactured...more

Farrell Fritz, P.C.

NY Court of Appeals Rejects Hospital’s Bid To Cloak Allegedly Defamatory FDA Investigation Statements With Absolute Immunity

Farrell Fritz, P.C. on

The recent New York Court of Appeals decision in Stega v. New York Downtown Hospital provides strong support for defamation claims arising out of witness testimony in investigations and quasi-judicial hearings....more

Cadwalader, Wickersham & Taft LLP

2016 Year In Review: Securities Litigation And Regulation

Cadwalader, Wickersham & Taft LLP on

2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

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