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

McDermott Will & Schulte

No Supremacy Clause Preemption Where State Statute Doesn’t Conflict With Federal

McDermott Will & Schulte on

The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However,...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

Jones Day

FDA on Board With Continuing Remote Inspections

Jones Day on

The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more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

Epstein Becker & Green

Unpacking Averages: Sample Size for Clinical Trials Used to Obtain FDA Medical Device Clearance

Epstein Becker & Green on

Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA? This month it is: how big...more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

Husch Blackwell LLP

Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

Husch Blackwell LLP on

On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more

Skadden, Arps, Slate, Meagher & Flom LLP

Trend Toward Broader Communication Continues as Congress Codifies Life Sciences Companies’ Ability To Share Product Information...

Skadden, Arps, Slate, Meagher & Flom LLP on

Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more

Morrison & Foerster LLP - Left Coast Appeals

This Week at the Ninth: Implied FDCA Preemption

Morrison & Foerster LLP - Left Coast Appeals on

This week, the Ninth Circuit addresses the statutory prohibition on private enforcement actions under the Food, Drug, and Cosmetic Act. The Court holds that a drug manufacturer’s suit against a compounding pharmacy for...more

Haug Partners LLP

A Tale of Two Orphans: The Potential Ramifications of an Orphan Drug “Cutting in Line”

Haug Partners LLP on

Orphan drugs are the pharmaceutical industry’s way of helping those who suffer from rare conditions. Thanks to the Orphan Drug Act, such patients can get the medications they need, and pharmaceutical companies can be duly...more

Hogan Lovells

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

Hogan Lovells on

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more

Womble Bond Dickinson

FDA Approves First of Its Kind Artificial Pancreas for Children 2 to 6 Years Old

Womble Bond Dickinson on

Type I Diabetes is the most common type of diabetes in children, impacting about 1 in 400 children in the US according to the American Diabetes Association. Children diagnosed with Type 1 diabetes require lifelong daily...more

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