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Biogen Pays $22 Million on Anti-Kickback Charges

[ Price : $8.95]

Biogen agrees to pay $22 million to resolve allegations that it violated the False Claims Act by illegally using two foundations a...

Info Collection on FDA Fellowship Applications

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for Application for Participation in FDA Fellowship ...

FDA Proposes Human Tissue Regulations Revocation

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Federal Register notice: FDA proposes to revoke the regulations for human tissue intended for transplantation and human dura mater...

FDA Issues EUA for Moderna Covid-19 Vaccine

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FDA issues an Emergency Use Authorization (EUA) for Modernas Covid-19 vaccine for use in individuals 18 years of age and older.

Guide on Generic Drug Controlled Correspondence

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Federal Register notice: FDA makes available a final guidance entitled Controlled Correspondence Related to Generic Drug Developme...

Guide on Dry Eye Drug Development

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Federal Register notice: FDA makes available a draft guidance entitled Dry Eye: Developing Drugs for Treatment.

FDA Updates Off-Patent, Off-Exclusivity List

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FDA posts the latest six-month update of its list of off-patent, off-exclusivity drugs without approved generics.

Phoenix Biotechnology Marketing Unapproved Covid Drug: FDA

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FDA warns Phoenix Biotechnology and Avila Herbals the Oleander 4X homeopathic drug they are marketing to address serious condition...

FDA 2020 Device Law and Policy Activities Analyzed

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Two Mintz attorneys review FDA medical device regulation and policy in 2020.

Change OTC Acetaminophen Childrens Dosage Schedule: Petition

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Parenteral Technologies asks FDA to amend the dosing schedule for single-ingredient acetaminophen for use in children ages 2-4.