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Food and Drug Administration (FDA) Enforcement Actions New Guidance

Foley & Lardner LLP

GLP-1 Drugs: Ohio Board of Pharmacy Issues FAQs for Compounders

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Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more

Hogan Lovells

FDA issues Guidance on Interim Animal Food Ingredient Consultation (AFIC) Process

Hogan Lovells on

On January 6, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) issued its final guidance on the interim Animal Food Ingredient Consultation (AFIC) process, which FDA positions as a...more

Foley Hoag LLP

FDA’s Major Statement: The Agency’s Recent Direct-to-Consumer CCN Final Rule, Q&A Guidance and Enforcement Trends

Foley Hoag LLP on

On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more

American Conference Institute (ACI)

[Event] 11th Legal, Regulatory & Compliance Forum on Dietary Supplements - June 28th - 29th, New York, NY

ACI and CRN are excited to welcome you back to New York City this Spring for the 11th Legal, Regulatory & Compliance Forum on Dietary Supplements. Since last year, there have been numerous important developments...more

King & Spalding

Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud

King & Spalding on

As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more

McGuireWoods LLP

FDA’s Emergency Use Authorization Process for COVID-19 Tests May Alleviate Shortage

McGuireWoods LLP on

As the nation battles shortages of novel coronavirus (COVID-19) testing kits, the U.S. Food and Drug Administration (FDA) has engaged its emergency use authorizations (EUA) process for unapproved products and uses to...more

Seyfarth Shaw LLP

The Week in Weed: December 2019

Seyfarth Shaw LLP on

Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. New Jersey is talking about decriminalizing marijuana. Regular readers will doubtless recall that legalization...more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

BCLP

Securities and Corporate Governance Update – October 2019

BCLP on

This newsletter discusses noteworthy updates, key regulatory decisions and upcoming compliance reminders. In this edition, we review: ...SEC Changes Approach to Shareholder Proposal No-Action Requests ...SEC Issues...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l October 2019

LEGISLATION, REGULATIONS & STANDARDS - House Passes Cannabis Banking Bill - The U.S. House of Representatives has passed the SAFE Banking Act, which allows financial-service firms to work with “cannabis-related...more

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

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On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

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