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Human Drugs

Guilty Pleas in Drug Kickback Conspiracy

The Justice Department says an Ohio doctor and an Avanir Pharmaceuticals employee have pleaded guilty to their roles in a drug kickback scheme.

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Human Drugs

New Requests in Radius Petition Supplement

Radius Health files a supplement to its earlier Tymlos petition with three additional actions it wants FDA to take.

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Medical Devices

Petition Seeks Reclassification of BD Mesh/Scaffolds

Cardiac surgeon Hooman Noorchashm petitions the agency asking it to change the classification of Becton Dickinsons poly 4-hydroxybutyrate (P4HB)-based...

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Human Drugs

Lawmakers Question FDA on Canadian Drug Importation

Six Republican lawmakers urge FDA commissioner Robert Califf to update them about an ongoing delay to review Floridas proposed Canadian Prescription D...

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Federal Register

Draft Guide on OTC Monograph Fees

Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program....

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Human Drugs

Comments on FDA Medical Queries

Two stakeholders comment on an FDA workshop on advancing premarket safety analytics.

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Human Drugs

Amazon Distributing Misbranded, Unapproved Drugs: FDA

FDA warns Amazon.com it is distributing unapproved new drugs.

Human Drugs

Violations at Sovereign Pharmaceuticals

FDA warns Fort Worth, TX-based Sovereign Pharmaceuticals about CGMP violations in its manufacturing and distribution of an unapproved biologic product...

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Human Drugs

Comments on ICH Pediatric Extrapolation Guidance

Two drug stakeholder associations raise questions and suggest changes to an International Council for Harmonization draft guidance on pediatric extrap...

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Human Drugs

Revised Expanded Access Q&A Guidance

FDA issues an updated question-and-answer draft guidance on expanded access to investigational drugs for treatment use.