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Federal Register

FDA Renews Medical Imaging Drugs Panel

Federal Register notice: FDA announces the renewal of its Medical Imaging Drugs Advisory Committee for an additional two years beyond the charter expi...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 5/3/2019.

FDA General

Product Approval Summaries

FDA Review post product approval summaries for the week ending 5/3/2019.

Federal Register

Priority Voucher Redeemed for Alexions Ultomiris

Federal Register notice: FDA announces the approval of product that redeemed a priority review voucher Alexion Pharmaceuticals Ultomiris (ravulizumab...

Federal Register

Update to Susceptibility Test Interpretive Criteria Page

Federal Register notice: FDA has made available its annual compilation of updates to the Susceptibility Test Interpretive Criteria Web page.

Federal Register

Patient Preference-Sensitive Priorities

Federal Register notice: FDA makes available a list of patient preference-sensitive priorities on FDAs Web site entitled Patient Preference-Sensitive ...

Human Drugs

Draft Guide on Developing ADHD Drugs

FDA posts a draft guidance entitled Attention Deficit Hyperactivity Disorder (ADHD): Developing Stimulant Drugs for Treatment.

Medical Devices

Treace Medical Bunion Pediatric Correction Cleared

FDA clears a Treace Medical Concepts 510(k) to expand indications of the Lapiplasty 3D Bunion Correction System to treat pediatric patients 12 years o...

Human Drugs

Woodcock Update on New Drugs Modernization Efforts

CDER director Janet Woodcock says the Center has six active initiatives ongoing as part of its new drugs regulatory program modernization.

Human Drugs

Hi-Tech Pharma Sues FDA on Action Against Supplements

Hi-Tech Pharmaceuticals sues FDA claiming that it bypassed standard rule-making procedures in favor of a campaign of intimidation to try to force comp...