Federal Register notice: FDA seeks comments on the drug industrys use of exposure-response analyses, particularly as it relates to recommendations in ...
Federal Register notice: FDA makes available a guidance entitled Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetic...
FDA clears a Sonoma Pharmaceuticals 510(k) for an antimicrobial post-therapy gel, intended for use in managing post-non-ablative laser therapy procedu...
FDA accepts an Antares Pharma NDA resubmission Xyosted (testosterone enanthate) injection for testosterone replacement therapy.
FDA approves an expanded Vascade indication to cover 5-7F femoral venous closures.
FDA finalizes a guidance on aspects of liposome drug products evaluated through NDAs and ANDAs reviewed by CDER.
FDA describes Benefit-Risk Framework enhancements to be implemented under PDUFA 6.
FDA issues a report outlining plans to develop and then implement new resource capacity planning and modernized time reporting capabilities.