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Federal Register notice: FDA seeks comments on an information collection extension on a guidance for Medical Device User Fee Small...[ Price : $8.95]
A Tufts Center for the Study of Drug Development analysis says the global biotech product development surge that started in the 19...[ Price : $8.95]
FDA issues a draft guidance on considerations for using a metastasis-free survival endpoint in some prostate cancer drug trials.[ Price : $8.95]
FDA releases its latest batch of Warning Letters that include StemGenex Biologic Laboratories and U.S. Vascular.[ Price : $8.95]
FDA accepts for review a Shire supplemental NDA to expand the indication of Gattex (teduglutide [rDNA origin]) for injection to pe...[ Price : $8.95]
Federal Register notice: FDA submits to OMB a new information collection entitled Surveys and Interviews With Investigational New ...[ Price : $8.95]
CDRH biomedical enginer Ifeanyi Uwemedimo explains provisions in a newly-finalized guidance on benefit-risk assessments for 510(k)...[ Price : $8.95]
FDA says it wants to give institutional review boards some greater flexibility to waive or alter informed consent requirements und...