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Human Drugs

Info Collection Extension for Biosimilar Meetings Guidance

Federal Register notice: FDA announces an opportunity for public comment on an information collection extension for the agency guidance entitled Forma...

Federal Register

Draft Guide on Epidermolysis Bullosa Drugs

Federal Register notice: FDA has made available a draft guidance entitled Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Mani...

Human Drugs

Canada Should Curb U.S. Drug Patents in Trade War: Professor

University of Ottawa law professor Amir Attaran suggests that the Canadian government should look at suspending U.S. drug patents as the Trump Adminis...

Federal Register

Comments Sought on Drug/Biologic Data Standard

Federal Register notice: FDA establishes a public docket to receive information, recommendations, and comments on matters related to its publication o...

Human Drugs

FDA Lifts Clinical Hold on Solid Bioscience Trial

FDA lifts a clinical hold against Solid Biosciences Phase 1/2 clinical trial for its investigational microdystrophin gene transfer, SGT-001, for treat...

Medical Devices

FDA Clears Arcuro Medical Meniscus Repair Device

FDA clears an Arcuro Medical 510(k) for its SuperBall meniscus repair system.

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 6/15/2018.

Human Drugs

Guide on Epidermolysis Bullosa Drug Development

FDA makes available a guidance entitled Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.

Federal Register

Class 2 for Prostate Tissue Jet System

Federal Register notice: FDA classifies the fluid jet system for prostate tissue removal into Class 2 (special controls).

Federal Register

Draft Guide on Certain Guidewire Submissions

Federal Register notice: FDA makes available a draft guidance entitled Coronary, Peripheral, and Neurovascular Guidewires Performance Tests and Recom...