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Judge Dismisses Lawsuit Against FDA by Whistleblowers

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A Washington DC federal judge dismisses a civil lawsuit brought by current and former CDRH whistleblowers because they failed to e...

Otto Bock C-Leg Petition Response Delayed

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FDA says its decision on a petition to reconsider a request to amend and revoke the 510(k) clearance of Otto Bock C-Leg requires a...

FDA Approves Boehringers Spiriva Respimat for COPD

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FDA approves Boehringer Ingelheim Pharmaceuticals NDA for Spiriva Respimat (tiotropium bromide) inhalation spray for treating bron...

FDA Approves AbbVies Humira for Pediatric Crohns

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FDA approves an AbbVie supplemental BLA for Humira (adalimumab) for reducing signs and symptoms, and achieving and maintaining cli...

Atty. Urges FDA to State Position on Device Social Promotion

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Attorney Jeffrey Shapiro says FDA and Congress should make clear whether medical device promotion through social media is labeling...

Clarifications Sought in Informed Consent Guidance

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Trade groups and drug companies raise questions and ask for clarifications in an FDA draft guidance on the informed consent inform...

Pacira Disputes FDA Warning on Exparel Promotions

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Pacira says it believes that, contrary to an FDA Warning Letter, its Exparel promotional materials are consistent with the current...

Rexahn Pancreatic Cancer Drug Gets Orphan Status

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FDA grants orphan drug designation to a Rexahn experimental pancreatic cancer drug.

FDA Orders Seizure of Kratom from California Company

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U.S. marshals seize more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management (Van Nuys,...

Generic Competitor for BioMarins Kuvan Notifies FDA

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BioMarin Pharmaceutical reports that FDA has received a Paragraph IV certification notice letter about an ANDA for a generic versi...