A Tufts Center for the Study of Drug Development analysis says the global biotech product development surge that started in the 1980s continues to gro...
FDA issues a draft guidance on considerations for using a metastasis-free survival endpoint in some prostate cancer drug trials.
FDA releases its latest batch of Warning Letters that include StemGenex Biologic Laboratories and U.S. Vascular.
FDA accepts for review a Shire supplemental NDA to expand the indication of Gattex (teduglutide [rDNA origin]) for injection to pediatric patients wit...
Federal Register notice: FDA submits to OMB a new information collection entitled Surveys and Interviews With Investigational New Drug (IND) Sponsors ...
CDRH biomedical enginer Ifeanyi Uwemedimo explains provisions in a newly-finalized guidance on benefit-risk assessments for 510(k) submissions.
FDA says it wants to give institutional review boards some greater flexibility to waive or alter informed consent requirements under some conditions.
Federal Register notice: FDA publishes a list of information collections that have been approved by OMB.