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Life Sciences › Biologics › Federal Food Drug and Cosmetic Act (FFDCA)

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FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision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As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

Sheppard Mullin Richter & Hampton LLP

FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company

Sheppard Mullin Richter & Hampton LLP on

On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 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

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

Quarles & Brady LLP on

On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...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

Hogan Lovells

FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

Hogan Lovells on

U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...more

Vicente LLP

Financing Adaptogenic Mushroom Companies: Seven Basic Regulatory Points to Understand

Vicente LLP on

Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year! (Part 2 of 3)

Mintz - Health Care Viewpoints on

Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more

MoFo Life Sciences

Pediatric Exclusivity For Biologics

MoFo Life Sciences on

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy...more

Faegre Drinker Biddle & Reath LLP

FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

Faegre Drinker Biddle & Reath LLP on

The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more

King & Spalding

General Counsels Decision Tree for Investigations of Life Sciences Companies

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Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more

Mintz - Health Care Viewpoints

GAO Report Sheds Light on Drug Manufacturers’ Expanded Access Programs

Mintz - Health Care Viewpoints on

Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more

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