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Justice Department Probe on Philips Respironics Recall

[ Price : $8.95]

The Department of Justice subpoenas Philips Respironics and certain other Philips subsidiaries in the U.S. for information on the ...

Export Notification/Recordkeeping Info Collection

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Export Notification and Recordkeeping Requi...

Autofluorescence Detection Device is Class 2

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Federal Register notice: FDA classifies the autofluorescence detection device for general surgery and dermatological use into Clas...

FDA Hits Wedgewood Connect with 483 After Inspection

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FDA issues a four-item Form FDA-483 to Wedgewood Connect after an inspection of its San Jose, CA drug manufacturing facility cited...

Xenotransplantation Guide Information Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled Public Health Service (PHS) Guideline on In...

FDA Probes DTC Promotional Claims Tradeoffs

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CDER's Office of Prescription Drug Promotion seeks comments on a research proposal to understand the Tradeoff Analysis of Prescrip...

CMC Issues Hinder Axsome NDA on Migraine Drug

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Axsome Therapeutics expects to receive a complete response letter on its NDA for migraine drug AXS-07 (meloxicam-rizatriptan) due ...

Lab Test Firms, Others Plead Guilty in Kickback Scheme

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Eleven defendants, including the founders of several lab companies, plead guilty in a $300 million scheme to pay kickbacks to indu...

Gileads Veklury OKd for Covid Pediatric Patients

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FDA expands the approval of Gilead Sciences Veklury (remdesivir) to include treating Covid-19 pediatric patients 28 days of age an...

Ardelyx Gets Panel Review on Tenapanor Appeal

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CDERs Office of New Drugs says it will convene its Cardiovascular and Renal Drug Advisory Committee to hear an appeal from Ardelyx...