[ Price : $8.95]
Federal Register Notice: FDA releases an ICH draft guidance: M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mu...[ Price : $8.95]
FDA rescinds due to GMP concerns its approval of a Sun Pharma NDA for Elepsia XR (levetiracetam) extended-release tablets 1,000 mg...[ Price : $8.95]
Southern Florida federal judge Edwin G. Torres approves a consent decree of permanent injunction against Sunset Natural Products a...[ Price : $8.95]
ReVision Optics files its fourth and final PMA module for the Raindrop Near Vision Inlay, a microscopic hydrogel inlay designed to...[ Price : $8.95]
FDA issues a final guidance on Controlled Correspondence Related to Generic Drug Development that gives advice on the process for ...[ Price : $8.95]
Federal Register Notice: FDA plans a public meeting 11/10 on the labeling for lower-dose vaginal estrogen products intended to tre...[ Price : $8.95]
Federal Register Notice: FDA plans a public meeting 12/18 on the reauthorization of the Biosimilar User Fee Act for fiscal years 2...[ Price : $8.95]
FDA posts a new International Conference on Harmonization guidance entitled M7(R1) Addendum to ICH M7: Assessment and Control of D...