News & Analysis as of

Comment Period Opioid Food and Drug Administration (FDA)

Perkins Coie

Regulatory Update: FDA Takes Action on Concentrated Kratom-Derivative Products

Perkins Coie on

On July 29, 2025, the U.S. Food and Drug Administration (FDA) announced its recommendation to schedule 7-hydroxymitragynine (7-OH)—a concentrated byproduct of the kratom plant—under the Controlled Substances Act (CSA)....more

Quarles & Brady LLP

FDA May Require Opioids to be Dispensed with Mail-Back Envelopes and Related Patient Education

Quarles & Brady LLP on

The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more

BakerHostetler

FDA and Pharmacy Weekly Digest - January 2020 #1

BakerHostetler on

Food/Dietary Supplements - FDA Releases Final Serving Size Guidance – The guidance is intended to “help manufacturers of packaged foods comply with the FDA’s updated Nutrition Facts labeling regulations. ...more

BakerHostetler

FDA and Pharmacy Weekly Digest - July 2019 #3

BakerHostetler on

Food/Dietary Supplements - FDA Issues Information for Food Producers Affected by Tropical Storm Barry – The FDA encouraged food producers to utilize established FDA guidance on evaluating the safety of flood-affected food...more

Hogan Lovells

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Hogan Lovells on

Agency seeks input on “comparative advantage” requirement for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more

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