FDA Review posts latest Federal Register for the week ending 4/7/2017.
FDA issues Merck a complete response letter on supplemental NDAs for sitagliptin-containing drugs that sought to add labeling based on results from TE...
CDRH officials provide their viewpoint on differing clinical trial considerations in producing data to justify marketing approval or clearance.
A United Therapeutic Corp. petition asks FDA not to approve a generic copy of Tyvasco (treprosrinil) if it determines that the proposed generic device...
FDA releases a guidance on Providing Regulatory Submissions in Electronic Format Certain Human Pharmaceutical Product Applications and Related Submis...
FDA clears a Qiagen 510(k) for the ipsogen JAK2 RGQ PCR Kit for detecting mutations affecting the Janus Tyrosine Kinase 2 gene.
Federal Register notice: FDA announces a 4/13 Antimicrobial Drugs Advisory Committee meeting on developing antibacterial drugs that treat a single spe...
FDA approves two Gilead Sciences supplemental NDAs for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus in chil...