Federal Register notice: FDA extends until 3/19 the comment period for its draft guidance on Demonstrating Substantial Evidence of Effectiveness for H...
Federal Register notice: FDA makes available a final guidance entitled Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual...
FDA seeks comments on two proposed studies entitled Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.
FDA accepts for review a Corium 505(b)(2) NDA for Adlarity (donepezil transdermal system) for treating Alzheimers-type dementia.
FDA clears a GT Medical Technologies 510(k) for GammaTile Therapy expanded use in surgically targeted radiation therapy in patients with malignant bra...
Federal Register notice: FDA releases two final guidances on drug interaction studies.
Federal Register notice: FDA issues a priority review voucher for the approval of a rare pediatric disease product application Sarepta Therapeutics V...
Federal Register notice: FDA makes available a revised draft guidance entitled Draft Guidance for Levonorgestrel.