OR WAIT null SECS
January 02, 2016
Amid corporate restructurings, regulatory initiatives, and aging R&D assets, will drug development accelerate or stall in 2016?
December 28, 2015
The FDA program that encourages biopharma companies to develop new treatments for rare and neglected diseases has been in the spotlight recently.
December 17, 2015
The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.
December 04, 2015
FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.
The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.
December 02, 2015
FDA confirmed quality focus while Congress moved to bolster biomedical innovation.
October 29, 2015
The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.
October 23, 2015
The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards
September 28, 2015
The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.
September 08, 2015
The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.