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Regulatory Requirements › FDA Approval › Regulatory Oversight

Latham & Watkins LLP

FDA Publishes Complete Response Letters for Unapproved Drug Applications

Latham & Watkins LLP on

On September 4, 2025, the US Food and Drug Administration (FDA or the Agency) announced that it released a second batch of complete response letters (CRLs) — which explain the Agency’s determination for refusing to approve a...more

Hogan Lovells

New FDA approval process promotes development of rare disease gene therapies

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The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more

Gardner Law

The Importance of a Clinical Trial Strategy

Gardner Law on

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

Loeb & Loeb LLP on

The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

Husch Blackwell LLP

Say Goodbye to the Red Dye: Legal Implications Following the FDA’s Recent Ban

Husch Blackwell LLP on

On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more

IR Global

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

IR Global on

In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more

Bradley Arant Boult Cummings LLP

FDA Chief Says CBD Is Not NBD, Urges Congressional Action

Bradley Arant Boult Cummings LLP on

Supporters of hemp-derived cannabidiol (CBD) who hoped the Food and Drug Administration would adopt a more progressive view of CBD were disappointed when FDA Chief Robert Califf recently testified that FDA does not consider...more

Akerman LLP - Health Law Rx

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

Akerman LLP - Health Law Rx on

At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies.  President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more

Hogan Lovells

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

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On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Cell and gene therapies

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more

Hogan Lovells

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers

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On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket approval) devices to class II (subject...more

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