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Astellas/Pfizer sNDA for Xtandi Gains Priority Review

[ Price : $8.95]

FDA grants Astellas Pharma and Pfizer a priority review for their supplemental NDA for Xtandi (enzalutamide) for treating men with...

Info Collection on Patent Term Restoration Petitions

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Federal Register notice: FDA seeks comments on an information collection extension for Patent Term Restoration; Due Diligence Peti...

BioElectronics 510(k) for Musculoskeletal Pain Patch

[ Price : $8.95]

BioElectronics files a 510(k) that seeks expanded clearance for its ActiPatch Musculoskeletal Pain Therapy for adjunctive treatmen...

2 Companies Settle Opioid Epidemic Cases for $15 Million

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Endo and Allergan agree to pay $15 million to settle a suit by two Ohio counties accusing several drug companies and drug distribu...

Peters Wants Drug Shortage Answers

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Sen. Gary Peters asks FDA acting commissioner Ned Sharpless to answer questions on the agencys current and future efforts to addre...

QS, Other Violations in Polymer Technology Inspection

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FDA warns Polymer Technology Systems about multiple violations in its manufacturing of in vitro diagnostic medical devices.

CGMP Violations at TG United

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FDA warns TG United about CGMP and other violations in its production of finished drugs.

Antimicrobial Drugs Panel to Review Antibiotic

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Federal Register notice: FDA announces a 10/16 Advisory Committee meeting to review a Shionogi NDA for antibiotic for urinary trac...

FDA Highlights GMP Warning to Chinese OTC Drug Maker

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FDA highlights a new Warning Letter to a Chinese drug manufacturer as evidence of its increased oversight of over-the-counter drug...

Panel to Review Agile Transdermal Contraceptive

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Federal Register notice: FDA sets a 10/30 advisory committee meeting to review an Agile Therapeutics transdermal contraceptive.