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KemPharm Files Dispute Resolution Request of Pain Drug

[ Price : $8.95]

KemPharm files a formal dispute resolution request over a June FDA complete response letter on an NDA for Apadaz (benzhydrocodone ...

FDA News Releases Get C Grade: Publication

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HealthNewsReview says that FDA product news releases often dont give sufficient detail and context to allow readers to make inform...

Court Sees Scienter in Arena Drug Case: Attorney

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Attorney Peter Hawkes says the 9th Circuit Court of Appeals overturned a lower court decision and found that Arena Pharmaceuticals...

FDA Clears Neural Analytics Transcranial Doppler Ultrasound

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FDA clears a Neural Analytics 510(k) for the Lucid M1 Transcranial Doppler Ultrasound System, a portable device designed for rapid...

FDA Clears Arterys Software for Cardiac Imaging

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FDA clears an Arterys 510(k) for its Arterys Software and its use in clinical settings for the quantification of cardiac flow (4D ...

Two Zika Tests Granted Emergency Use Authorizations

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Federal Register Notice. FDA announces the issuance of two emergency use authorizations for in vitro diagnostic devices for detect...

Comments Sought on Emergency Plan Guidance Extension

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Federal Register Notice: FDA asks for comments on an OMB submission seeking an information collection extension on the guidance Pl...

Comments Sought on Informed Consent Requirements Estension

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Federal Register Notice: FDA asks for comments on a request for OMB to extend an information collection on The Protection of Human...

Spectranetics PMA for Drug-Coated Angioplasty Balloon

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Spectranetics Corp. files a PMA for the Stellarex drug-coated angioplasty balloon, for use in restoring and maintaining blood flow...

Race, Ethnicity Data Collection Guidance

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FDA issues a guidance on collecting race and ethnicity data for clinical trial submissions.