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Life Sciences Biologics Manufacturers

Morgan Lewis - As Prescribed

FDA’s New Priority Voucher Program for Drug Developers Ties Incentives to Defined National Interests

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors...more

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

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

Baker Donelson on

What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

Goodwin on

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Paul Hastings LLP

Post-COVID Checkup: Current FDA Due Diligence Considerations

Paul Hastings LLP on

The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more

Goodwin

Navigating the New Normal: Biomanufacturing Goes Local

Goodwin on

The pandemic has spared no industry. As fast-food chains have sought to drive business through chicken sandwich wars, Burger King’s release of its chicken sandwich was delayed in Michigan due to a shortage of pickle jars....more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Hogan Lovells

FDA advises drug manufacturers on best practices for restarting operations during COVID-19 pandemic

Hogan Lovells on

On September 11, the U.S. Food and Drug Administration (FDA) issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” urging drug manufacturers to...more

Epstein Becker & Green

Current Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk...

Epstein Becker & Green on

FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance”) which provides...more

Sheppard Mullin Richter & Hampton LLP

Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison...

2019 ushered in numerous changes and new initiatives at the U.S. Food and Drug Administration (FDA). From the increasing popularity of cannabis use to the rapidly evolving nature of artificial intelligence in medical devices,...more

Morgan Lewis

Federal Circuit Acetris Decision Is Important for Pharmaceutical Manufacturers Planning Sales to US Government

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The US Court of Appeals for the Federal Circuit’s February 10 decision in Acetris Health, LLC v. United States provides important guidance regarding the determination of a product’s country of origin, which is a gating issue...more

Troutman Pepper Locke

Third Circuit Provides Manufacturers With Roadmap to Avoid Class Antitrust Claims Brought by Direct Purchasers

Troutman Pepper Locke on

The Third Circuit recently held in In re Remicade (Direct Purchaser) Antitrust Litigation that a direct purchaser’s antitrust suit alleging overpayment for a drug purchased pursuant to a distribution agreement with a...more

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