10.20.2020

Cooperative Manufacturing Arrangements for Licensed Biologics

This is the Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics.
10.20.2020

Radioactive Drug Research Committee (RDRC) Program

Regulating the use of radioactive drugs in basic research
10.20.2020

What will FDA's experts review at their first COVID-19 vaccine hearing? Agency documents set the tone

What will FDA's experts review at their first COVID-19 vaccine hearing? Agency documents set the tone esagonowsky Tue, 10/20/2020 - 11:10
10.20.2020

List of Drug Master Files (DMFs)

The list is updated quarterly. Changes are made to the DMF activity status, DMF type, holder name, and subject.
10.20.2020

Warning Letters 2020

Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.
10.20.2020

Warning Letters 2018

These letters are supplied by the CDER Freedom of Electronic Information Office.
10.20.2020

Efficacy Supplement Approvals

Efficacy Supplement Approvals
10.20.2020

Drugs

Consumer articles about over-the-counter and prescription drugs.
10.20.2020

User Fee Lists

Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016.
10.20.2020

Black Americans more skeptical than ever about COVID-19 vaccine: Harris Poll

Black Americans more skeptical than ever about COVID-19 vaccine: Harris Poll bbulik Tue, 10/20/2020 - 10:32