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Sweeping Changes Coming to OTC Monographs: Attorneys

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Mintz Levin attorneys say FDA and industry will need to quickly adapt to OTC monograph reform provisions included in the CARES Act...

Expand PPI Label Warnings: Petition

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The Alliance for Natural Health USA asks FDA to require manufacturers of proton pump inhibitors to include a Warning statement abo...

ANDA Conversion Under Court Order MAPP

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FDA issues a CDER MAPP on converting approved ANDAs to temporary approval after receiving a court decision on patent infringement.

CNS Pharma Orphan Status for Berubicin

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FDA grants CNS Pharmaceuticals an orphan drug designation for its lead product berubicin for treating malignant gliomas.

FDA Approves BMS Opdivo for Some Cancer Patients

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FDA approves Bristol-Myers Squibbs Opdivo for esophageal squamous cell cancer.

Web Sites Offering Unapproved Covid Iodine Products

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FDA warns the owner of OutoftheBoxRemedies.com that it and other Web sites are selling unapproved and misbranded iodine products t...

FDA Approves Pfizers Nyvepria

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FDA approves Pfizers Nyvepria, a biosimilar to Amgens Neulasta.

Info Collection Revision on Device Fee Cover Sheet

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Federal Register notice: FDA seeks comments on an information collection revision for Medical Device User Fee Cover Sheet, Form FD...

Web Site Selling Essential Oils as Covid Treatment: FDA, FTC

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FDA and FTC say the Web site organic-beauty-recipes.com is promoting essential oils that claim to prevent, treat, or cure Covid-19...

Curis Gets FDA Go Ahead for Anti-Vista Antibody

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FDA approves a Curis IND application for CI-8993, which it describes as the first-in-class monoclonal anti-Vista antibody, for a P...