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Info Collection on Humanitarian Use Devices

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Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Devices; Humanitarian Use Devices (H...

Device Labeling Info Collection

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Federal Register notice: FDA seeks comments on an information collection revision entitled Medical Device Labeling Regulations.

Amazon Warning Letter Raises Questions: Attorneys

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Two Mintz attorneys discuss questions raised by a recent FDA Warning Letter involving the Amazon.com fulfillment service that deli...

Pull IPOL Polio Vaccine Until Better Trial Held: ICAN

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The Informed Consent Action Network says FDA should withdraw approval of the IPOL polio vaccine until adequate clinical trials dem...

FDA Denies Petition Seeking Freeze on Russia-based Applications

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FDA denies a citizen petition seeking a freeze on all regulatory requests from pharmaceutical and medical device companies headqua...

Surgaligns Cortera Spinal Fixation Device Cleared

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FDA clears a Surgalign Holdings 510(k) for its Cortera Spinal Fixation System.

Draft Guide on Charging for Investigational Drugs

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Federal Register notice: FDA makes available a revised draft guidance for industry entitled Charging for Investigational Drugs Und...

Panel To Discuss CDER Quality Management Proposal

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Federal Register notice: FDA announces an 11/2-3 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting to di...

GSK Opposes Teva Coreg Skinny Label Appeal

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GlaxoSmithKline asks the Supreme Court not to hear Tevas appeal of a federal appeals court decision in a case involving a so-calle...

Stakeholders Want More Drug Shortage Mitigation Info

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Two stakeholders raise questions about an FDA draft guidance on risk management plans to mitigate drug shortages.