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FDA General

Gottlieb Added to Pfizer Board

Pfizer adds former FDA commissioner Scott Gottlieb to its board of directors.

FDA General

CLOSED FOR THE FOURTH OF JULY

In observance of the Fourth of July (Independence Day)holiday in the U.S., the news operations of Dickinson's FDA Webview are closed until Monday, Jul...

FDA General

Pallone Wants Imported Cosmetics Update

House Energy and Commerce Committee chairman Frank Pallone asks FDA for updated information on inspections of imported cosmetics.

Human Drugs

FDA Proposes Easing Biologics Transition

FDA proposes to allow some biologic products to continue to reference drug master file information after transitioning to Public Health Service Act li...

Human Drugs

ICH M10 Guidance Released

FDA publishes an International Council on Harmonization guideline on validation of bioanalytical assays for chemical and biological drug quantificatio...

Human Drugs

Complex Innovative Design Pilot Videos Posted

FDA posts videos explaining its Complex Innovative Trial Design pilot meeting program.

Human Drugs

Heart Failure Drug Development Guidance

FDA issues a draft guidance on developing drugs to treat heart failure.

Federal Register

Drug Safety Data Collection Guide

Federal Register notice: FDA makes available a draft guide entitled E19 Optimization of Safety Data Collection.

Federal Register

Guide on Diagnostic Ultrasound Systems/Transducers

Federal Register notice: FDA makes available a final guidance entitled Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.

Federal Register

Comments Sought on Clinical Data Summary Pilot

Federal Register notice: FDA seeks public comment on its Clinical Data Summary Report Pilot program as part of the agencys continuous assessment of th...