Jeff Weinstein

"Out There" Columnist at ArtsJournal

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Articles

New SEC Leadership Signals Continued Focus on FDA-Related Disclosures | JD Supra

1 month ago | jdsupra.com | Eugene Goldman |Paul Helms |Jeff Weinstein

CURRENT SEC ENFORCEMENT REGARDING FDA-RELATED INFORMATIONOn March 12, 2025, the SEC filed suit against three former Allarity Therapeutics, Inc. executives for allegedly scheming to conceal harsh feedback from the FDA regarding Allarity’s flagship cancer drug candidate.
Preparing for 2025: Key Trends in FDA Guidance Agendas

2 months ago | lexology.com | James Ravitz |Paul S. Gadiock |Michael Ryan |Jeff Weinstein |Marissa Daley |Karis Jackson | +2 more

In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities, suggesting where industry stakeholders might encounter new oversight-related opportunities and challenges in the coming year. These guidance agendas are not set in stone, however.
FDA Relaxes on Use of Scientific Info in Off-Label Communications | JD Supra

2 months ago | jdsupra.com | Paul S. Gadiock |James Ravitz |Jeff Weinstein

Overview On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” The guidance finalizes FDA’s revised draft guidance issued in October 2023 concerning firm-initiated communications of scientific information on unapproved uses (SIUU) of approved or cleared medical products to healthcare...
EXPERT INSIGHTS-FDA'S FRESH TAKE ON USE OF HEALTHY IN FOOD LABELING

Jan 13, 2025 | today.westlaw.com | James Ravitz |Paul S. Gadiock |Jeff Weinstein |Marissa Daley

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FDA's Fresh Take On Use Of "Healthy" In Food Labeling

Jan 10, 2025 | mondaq.com | James Ravitz |Paul S. Gadiock |Jeff Weinstein |Marissa Daley

On December 19, 2024, the US Food and Drug Administration (FDA)issued a new final rule titled "Food Labeling: Nutrient Content Claims; Definitionof Term 'Healthy.'" The rule revises regulationsthat govern when food products may be labeled as"healthy" and when a derivative term (e.g.,"health," "healthful," or"healthier") may be used to make a claim about theproduct's nutritional content.
FDA’s Fresh Take on Use of “Healthy” in Food Labeling | JD Supra

Jan 8, 2025 | jdsupra.com | Jeff Weinstein
FDA Seeks Comments on Updates to MoCRA Guidance on Registration, Listing of Cosmetic Product Facilities | JD Supra

Dec 26, 2024 | jdsupra.com | Jeff Weinstein

On December 11, 2024, the US Food and Drug Administration (FDA) updated its Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. As discussed in our previous On the Subject, FDA released the original version of the final guidance in December 2023 as required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
CDRH Looks Ahead With FY 2025 Proposed Guidance Agenda | JD Supra

Dec 16, 2024 | jdsupra.com | Jeff Weinstein

OverviewOn October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in the 2025 fiscal year (FY).
Real-World Data Back in the Spotlight at FDA

Aug 12, 2024 | lexology.com | James Ravitz |Jiayan Chen |Paul S. Gadiock |Jennifer S. Geetter |Jeff Weinstein |Sam Siegfried | +2 more

On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance.
The Three Faces of Grieve

Aug 8, 2024 | villagevoice.com | Jeff Weinstein |Tom Carson |Ross Barkan |Frank Pizzoli

Where’s that orange paperback, Art Deco, by Bevis Hillier? Michael Gass, my sparkling actor-boyfriend at Brandeis University, in Massachusetts, handed it to me in 1968, his sophomore, my senior year. The jewel of a book proposed the beauty of a reviving style he thought I would like — and would help me to get to know him better. More important, he let me wear and ultimately keep his baggy, deco-chevroned sweater, which I wish I had held onto.