[ Price : $8.95]
Adamas Pharmaceuticals files an NDA for ADS-5102 (amantadine hydrochloride) extended-release capsules, indicated for treating levo...[ Price : $8.95]
FDA clears a SeaSpine Holdings 510(k) for its Shoreline ACS Anterior Cervical Standalone System, which features TruProfile technol...[ Price : $8.95]
Salix asks FDA to require several specific test results for any ANDA citing any strength or indication of Xifaxan as the reference...[ Price : $8.95]
FDA publishes generic drug regulatory science priorities for FY 2017.[ Price : $8.95]
FDA awards Engility Holdings a $112 million five-year contract for computational science and bioinformatics services.[ Price : $8.95]
FDA says that new data indicate continuing increased mortality and neurological risks with use of SynCardias Temporary Total Artif...[ Price : $8.95]
The CDER Office of Generic Drugs issues a MAPP with policies and procedures for review of Bio-INDs.[ Price : $8.95]
Two stakeholders suggest improvements to an FDA/HHS guidance on written procedures for institutional review boards.