OR WAIT null SECS
April 16, 2015
FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.
March 23, 2015
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.
February 11, 2015
The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.
December 19, 2014
FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.
The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.
December 17, 2014
The agency publishes two guidance documents on providing regulatory submissions in electronic format.
December 15, 2014
The agency expresses its support for the adaptive pathway approach to bringing new drugs to patients.
December 01, 2014
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
July 10, 2014
FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.
June 12, 2014
Draft guidance from FDA includes information essential for the completion of ANDA applications.