James Ravitz

McDermott Will & Emery

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Latest Posts › Regulatory Reform

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Quit Monkeying Around: FDA Offers Faster Approval Times in Bid to Phase Out Animal Testing

On April 10, 2025, the US Food and Drug Administration (FDA) announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug...more

5/8/2025 / Animal Testing , Artificial Intelligence , Emerging Technologies , Food and Drug Administration (FDA) , Innovative Technology , Machine Learning , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Regulatory Requirements

Will It (Puff, Puff) Pass? Cannabis Reform Under the Trump Administration

The Trump administration’s approach to cannabis reform will significantly impact the industry. As the proposed rulemaking to reschedule cannabis unfolds and nominees to critical agencies are confirmed, it is crucial for...more

3/10/2025 / Cannabis Products , Controlled Substances , DEA , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Food and Drug Administration (FDA) , Marijuana , Proposed Rules , Regulatory Reform , Trump Administration

FDA Publishes Proposed Rule on Sections 503A and 503B Compounding

On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more

4/5/2024 / Abbreviated New Drug Application (ANDA) , Food & Drug Regulations , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Pharmaceutical Industry , Pharmacies , Proposed Rules , Regulatory Agenda , Regulatory Reform

FDA Releases Final Guidance on New Dietary Ingredient Notification Procedures and Timeframes

On March 5, 2024, the US Food & Drug Administration (FDA) released final guidance titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance is meant to...more

3/27/2024 / Dietary Supplements , Draft Guidance , Final Guidance , Food and Drug Administration (FDA) , Labeling , Notifications , Regulatory Reform

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