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Draft Guidance on Pharmacokinetic Analyses Format/Content

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FDA releases a draft guidance on Physiologically Based Pharmacokinetic Analyses Format and Content that outlines the recommended ...

Fast Track for Staph Aureus Pneumonia Therapy

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FDA grants Arsanis fast track status for ASN100 for preventing Staphylococcus aureus pneumonia in mechanically ventilated patients...

Stem Cell Anecdotal Claims Worrisome: Califf

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FDA commissioner Robert Califf says that approval of stem-cell therapies should be based on scientific evidence.

Medtronic Recalls Neurovascular Products

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FDA says Medtronic has recalled four neurovascular products due to the risk of coating separation and detachment.

Cures Act Promises FDA $500 mil. More, Heads to Senate

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After a 392-26 passage in the House, the 21st Century Cures Act heads to the Senate and could see a vote as early as next week.

FDA Priority Review for Mercks Keytruda in Lymphoma

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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients ...

FDA Clears BrightWater 510(k) for Nephroureteral Stent System

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FDA clears a BrightWater Medical 510(k) for the ConvertX Nephroureteral Stent System for treating ureteral obstructions, which pre...

FDA Updates REMS List

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FDA updates six REMS, including approval of a REMS for Novo Nordisks Xultophy.

FDA Addicted to Industry Money: POGO Reports

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Two Project on Government Oversight reports call for an end to user fees that the group says make FDA too financially dependent on...

Egalet sNDA Seeks Abuse-deterrent Claim for Oxaydo

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Egalet Corp. files a supplemental NDA for Oxaydo (oxycodone HCl) tablets for an abuse-deterrent label claim for the intravenous ro...