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Pharmaceutical Industry › Food and Drug Administration (FDA) › Licensing Rules

Foley Hoag LLP

FDA Releases First New COVID-19 Vaccine BLA Guidance Since 2020

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Executive Summary - On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more

Foley & Lardner LLP

Strengthening the Flow of the Biotech Sector’s M&A Pipeline

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Originally published in Genetic Engineering News on October 10, 2023. Reprinted with permission. The biotechnology sector has long been characterized by its constant innovation, rapid technological progress, and unyielding...more

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

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On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

Foley Hoag LLP

Next Up: Uniform Licensure Standards for Wholesalers and Third-Party Logistics Providers

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Key Takeaways: ▪️ FDA has published a proposed rule proposing national licensing standards for prescription drug wholesale distributors and third-party logistics providers as well as standards for third-party accreditation...more

Jones Day

FDA Proposes National Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

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The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more

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

FDA Issues Biosimilar Guidance for Label Carve-Outs and Supplements

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

On February 6, 2020, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance (“Guidance”) that addresses the licensure of a biosimilar or biosimilar interchangeable product for fewer than all of the conditions...more

Goodwin

FDA Issues Draft Guidance On Biosimilar Licensure For Fewer Than All Conditions Licensed for Reference Product

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The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”  In this guidance, the FDA...more

Burns & Levinson LLP

High Hopes and Torched Dreams

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This week’s cannabis news was filled with high hopes for some and torched dreams for others. On the one hand, the Food and Drug Administration made history by approving Epidiolex, a cannabis-derived medication used in the...more

Saul Ewing LLP

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

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Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Issues Its First Decision Interpreting BPCIA

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The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more

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