March 21, 2020

Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions. FDA uses RWD and RWE to monitor postmarket safety and […]
March 20, 2020

Requesting a Pre-Assigned Application number

Pre-assigned ANDA, NDA, BLA, IND, and MF number requests can now be submitted via the CDER NextGen Portal. New! the Portal is now accepting CDER Research IND […]
March 20, 2020

Post Award Grantee Information

Quarterly Reports will be required typically every three months from the date the grant was issued. Information including, but not limited to, information regarding study progress, […]
March 20, 2020

Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics

Image CaptionScientist processing Ebola virus disease samples at Donka Hospital in Conakry, Guinea as part of the EVIDENT project. (Credit: EVIDENT) About | Background | Project […]
March 20, 2020

FDALabel: Full-Text Search of Drug Labeling

FDALabel: Full-Text Search of Drug Labeling | FDA FDALabel (version 2.4) beta testing in progress Provide feedback or request assistance by contacting: Dr. Hong Fang (870-543-7538) […]
March 20, 2020

Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

Docket Number: FDA-2020-D-1106 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]
March 19, 2020

Drug Alerts and Statements

Drug Alerts and Statements | FDA In this section: Drug Safety and Availability Home Drugs Drug Safety and Availability Drug Alerts and Statements Drug Safety and […]
March 19, 2020

FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19

[3/19/2020] FDA is aware of news reports stating the use of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, could worsen coronavirus disease (COVID-19). These news reports […]
March 19, 2020

Developing Products for Rare Diseases & Conditions

On this page: About OOPD OOPD Programs Resources OOPD Contact Information About OOPD The FDA Office of Orphan Products Development (OOPD) mission is to advance the […]
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