Yes, I am starting a new thread! There has been so much speculation on various threads: when will we hear the news? From MSB? FDA? Finally found some really good information sources; so thought we could concentrate future discussion / speculation on FDA drug approval and media policies and procedures here.


Center for Drug Evaluation and Research | CDER

https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder


Development & Approval Process | Drugs

https://www.fda.gov/drugs/development-approval-process-drugs

Types of applications

https://www.fda.gov/drugs/how-drugs-are-developed-and-approved/types-applications
https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application


Center for Biologics Evaluation and Research (CBER) Development & Approval Process

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber

FDA Division of Communication

https://www.fda.gov/about-fda/cdrh-offices/division-communication



Guidelines on the Provision of Information to the News Media

http://www.hhs.gov/sites/default/files/media_policy.pdf


I found the above link buried in the following document:

FDA's External Communications

https://www.fda.gov/media/100885/download

NDAs and BLAs: Communication to Applicants of Planned Review Timelines

https://www.fda.gov/media/72710/download
Best Practices for Communication Between IND Sponsors and FDA
During Drug Development: Guidance for Industry and Review Staff

https://www.fda.gov/media/94850/download

MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp