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Human Drugs

Clinical Hold Placed on Ziopharm Leukemia Trial

FDA issues a clinical hold on a Ziopharm Oncology Phase 1 trial to evaluate CD19-specific CAR-T therapies manufactured under point-of-care, and reques...

Human Drugs

Complete Response Letter on Ortho Psoriasis Lotion

FDA issues Ortho Dermatologics a complete response letter on its NDA for Duobrii (halobetasol propionate and tazarotene) lotion and its use in treatin...

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Federal Register notice: FDA has made available a draft guidance entitled Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Mani...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

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Federal Register notice: FDA makes available a draft guidance entitled Coronary, Peripheral, and Neurovascular Guidewires Performance Tests and Recom...