A Nature editorial says FDA needs help from academic scientists to review and approve new drug therapies because in-house talent is weak.
FDA clears a Mauna Kea Technologies 510(k) for its CelioFlex UHD Confocal Miniprobes for use with the companys Cellvizio laser endomicroscopy platform...
Federal Register notice: FDA announces the availability of 48 final product-specific guidances that recommend the design of bioequivalence studies to ...
Federal Register notice: FDA announces a 9/19 Oncologic Drugs Advisory Committee meeting to review a C.P. Pharmaceuticals supplemental NDA for Sutent.
FDA approves a Teva Pharmaceutical Industries NDA for Qvar RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler f...
Federal Register notice: FDA announces a 9/13 Vaccines and Related Biological Products Advisory Committee meeting that will review GlaxoSmithKline Bio...
FDA issues Vernalis a complete response letter on its NDA for CCP-08, an undisclosed extended-release product being developed for Vernalis by Tris Pha...
FDA Review posts the Federal Register notices for the week ending 8/4/2017.