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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

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Federal Register notice: FDA has made available a draft guidance entitled Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Mani...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

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...

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Federal Register notice: FDA makes available a draft guidance entitled Coronary, Peripheral, and Neurovascular Guidewires Performance Tests and Recom...

Human Drugs

ICH Guide on S9 Nonclinical Anticancer Drug Trials

FDA posts an ICH guidance entitled S9 Nonclinical Evaluation for Anticancer Pharmaceuticals: Questions and Answers.

Federal Register

Guide on Intravascular Catheters, Wires with Lubricious Coatings

Federal Register notice: FDA makes available a draft guidance entitled Intravascular Catheters, Wires, and Delivery Systems with Lubricious CoatingsLa...