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Mintz - Health Care Viewpoints

FDA in Flux — August 2025 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

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Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

MoFo Life Sciences

The EU’S New Proposal For Plants Developed Using New Genomic Techniques: How Does It Compare To U.S. Regulation?

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After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post....more

BakerHostetler

FDA and Pharmacy Weekly Digest - October 2020 #1

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FDA Released Food Traceability Proposed Rule – The United States Food and Drug Administration (FDA) is proposing to establish additional traceability recordkeeping requirements for manufacturers, processors, packers or...more

BakerHostetler

FDA and Pharmacy Weekly Digest - January 2020 #2

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Food/Dietary Supplements - Court Enters Consent Decree Against Food Facility – A Michigan-based food manufacturer will “discontinue selling food products until the company complies with federal regulations and other...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues

Letters and Statements - Gene Therapy: Democratic Senators Urge the FDA to Hold Company Accountable for Falsifying Data - On August 9, 2019, a group of Democratic senators, including two presidential candidates, sent...more

BakerHostetler

FDA and Pharmacy Weekly Digest - April 2019 #3

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Food/Dietary Supplements - Agencies Announce Food Waste Reduction Strategy – The FDA, USDA and EPA released a food waste strategy. ...more

BakerHostetler

FDA and Pharmacy Weekly Digest - March 2019 #2

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FDA Commissioner Announces Resignation – Food and Drug Administration Commissioner Scott Gottlieb announced his resignation, citing personal reasons. ...more

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - November 2018 #4

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Food/Dietary Supplements - Romaine Lettuce Investigation – The Food and Drug Administration (FDA) is investigating a multistate outbreak of E. coli likely linked to romaine lettuce....more

McGuireWoods LLP

Fireworks for Animal Drug Compounding at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part Two...

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The second day began with a deep dive into the development of advanced biological drugs for animal use. David Brake, Ph.D., Founder and Principal, BioQuest Associates, LLC, helped explain the split between USDA and FDA...more

McGuireWoods LLP

Fireworks for Animal Compounding and More at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part...

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On September 10-11, the American Conference Institute (ACI) held its inaugural Animal Health and Veterinary Drugs and Therapeutics Conference in New York City. The Conference featured two workshops: a pre-conference overview...more

BakerHostetler

First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

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A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more

Snell & Wilmer

Product Recall Trends in 2015

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What are the latest trends on product recalls in the United States? Consumer Products. The Consumer Product Safety Commission has been proactive in recent years with consumer product regulations and recalls,...more

Troutman Pepper

Disposing Of Pharmaceutical Waste: Some Progress

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In 2008, the U.S. Environmental Protection Agency (EPA) seemed to be on the road to providing some much-needed clarity to hospitals and other medical facilities concerning the disposal of pharmaceuticals by proposing that...more

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