FDA grants Allergan a fast track designation for AGN-241751, an investigational new treatment for major depressive disorder.
FDA accepts for review an Aerie Pharmaceuticals 505(b)(2) NDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a once-daily eye...
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-specific recommendatio...
FDA clears a NeuMoDx Molecular 510(k) for its NeuMoDx 288 Molecular System and its NeuMoDx GBS [Group B Streptococcus] Assay.
FDA Review posts product approval summaries for the week ending 7/22/2018.
FDA posts 43 product-specific guidances (26 new guidances and 17 revised guidances) that describe the agencys current thinking and expectations on how...
Federal Register notice: FDA reopens the comment period for its Metered Dose Inhaler and Dry Powder Inhaler Drug Products Quality Considerations; Dra...
Federal Register notice: FDA extends the comment period until 10/18 for a guidance entitled Documenting Electronic Data Files and Statistical Analysis...