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Converted OTC Products are Not Listed Drugs: FDA

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Attorney Michael Shumsky explains how a previously unknown FDA administrative change can allow NDA holders to gut the 180-day excl...

Mexican Firm Refuses FDA Inspection

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FDA warns Mexicos Glicerinas Industriales that its drug products are adulterated because the company refused to allow an FDA inspe...

Appeals Court Upholds WV Law on Misleading Lawyer Ads

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Two Shook, Hardy attorneys say the 4th Circuit Court of Appeals has upheld a West Virginia law restricting ways in which plaintiff...

CBER Pilot Program for 510(k) eSubmissions

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Federal Register notice: CBER announces a voluntary pilot program for sponsors of CBER-regulated 510(k) submissions entitled Elect...

Guide on Power Morcellator Containment Devices

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Federal Register notice: FDA makes available a draft guidance entitled Non-Clinical Performance Assessment of Tissue Containment S...

FDA Panel Shoots Down Acadia Alzheimers sNDA

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An FDA advisory committee votes 9-3 to not recommend approval of an Acadia Pharmaceutical resubmitted sNDA for Nuplazid (pimavanse...

FDA Denies ICAN Covid Vaccine Petition

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FDA denies a petition from the Informed Consent Action Network asking that it not approve Covid-19 vaccines for youths ages 12-17.

Supply Chain Changes Needed to Ease Drug Shortages: FDA

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An FDA annual report to Congress on drug shortages in 2021 identifies two supply chain needs that must be worked on.

Reform Paragraph 4 Certification Process: Analysis

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A Health Affairs analysis from West Health Policy Center suggests two reforms for the Waxman-Hatch Paragraph 4 process that could ...