CDER director Janet Woodcock says FDA is looking for ways to expand use of real-world data in generating evidence of a drugs effectiveness.
FDA announces three initiatives called for in the MDUFA reauthorization to aid medical device development, innovation, and safety.
Attorney James Czaban reviews the steps FDA is taking to affect drug prices despite lacking specific direct authority in that area.
FDA releases inspection reports for 2016 and 2017 for Chinas Zhejiang Huahai Pharmacetical Co., maker of active pharmaceutical ingredient involved in ...
Federal Register notice: FDA announces a 10/3 Vaccines and Related Biological Products Advisory Committee meeting.
Federal Register notice: FDA seeks comments on a new information collection entitled Surveys and Interviews With Investigational New Drug (IND) Sponso...
A Healthcare IT News analysis says the medical device industry and FDA are moving in the right direction to improve medical device security.
FDA commissioner Scott Gottlieb announces a 9/17 workshop on microbiome-based products and their use in preventing, treating, and curing diseases in h...