News & Analysis as of

Safety Precautions Pharmaceutical Industry

Fitch, Even, Tabin & Flannery LLP

Federal Circuit Will Not Read Safety and Efficacy Limitations into Pharma Method Claims

On July 24, in United Therapeutics Corporation v. Liquidia Technologies, Inc., the Federal Circuit addressed whether safety and efficacy are required for pharmaceutical method claims to be sufficiently enabled and supported...more

McDermott Will & Emery

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

McDermott Will & Emery on

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

King & Spalding

U.S. Customs And Border Protection Announces Three New Members Of Commercial Targeting And Analysis Center

King & Spalding on

Participating agencies jointly target commercial imports that threaten health and safety - U.S. Customs and Border Protection (CBP) announced on April 1 that three additional Federal agencies have formally joined the...more

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