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Sen. Schumer Seeks FTC Review on Home DNA Kits

[ Price : $8.95]

Sen. Chuck Schumer (D-NY) calls on the Federal Trade Commission to examine direct-to-consumer home DNA kits to ensure genetic info...

Draft Guide on Grandfathering Drugs Sans Product Identifiers

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Grandfathering Policy for Packages and Homogenous Cases of ...

Workshop on IND Safety Assessment Reporting

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Federal Register notice: FDA announces a 1/11/2018 public workshop entitled Safety Assessment for IND Safety Reporting.

Sun Pharma Recalls 2 Riomet Contaminated Lots

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Sun Pharmaceutical Industries recalls two lots of Riomet (metformin hydrochloride oral solution), 500 mg/5mL, due to Scopulariopsi...

Pediatric X-ray Guidance for 510(k) Submissions

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FDA posts a guidance on Pediatric Information for X-ray Imaging Device Premarket Notifications that outlines the agencys current t...

BioMarin Sells Priority Review for $125 Million

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BioMarin Pharmaceutical agrees to sell for $125 million its Rare Pediatric Disease Priority Review Voucher it was awarded by FDA i...

Ex-Pharmakon Compliance Director Pleads Guilty to Drug Adulteration

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A former compliance director at Indiana compounding pharmacy Pharmakon Pharmaceuticals pleads guilty to introducing adulterated dr...

Guide on Generic Abuse-deterrent Opioids

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Federal Register notice: FDA makes available a guidance entitled General Principles for Evaluating the Abuse Deterrence of Generic...

Panel to Review Clarus Therapeutics Testosterone Replacement

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Federal Register notice: FDA announces a 1/9/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting in Hyattsville,...

10th Annual Sentinel Public Workshop

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Federal Register notice: FDA announces a 2/7-8/2018 public workshop entitled Tenth Annual Sentinel Initiative Public Workshop.