CBER creates a new dialog avenue for biologic product developers to ask agency experts for advice on advancing a potential product.
Federal Register notice: FDA submits for OMB approval an information collection revision entitled Guidance for Industry: Assessing User Fees Under the...
FDA approves a GW Research NDA for Epidiolex (cannabidiol) oral solution for treating seizures associated with two rare and severe forms of epilepsy, ...
FDA approves a Glaukos Corp. PMA for the iStent inject Trabecular Micro-Bypass System, indicated for reducing intraocular pressure in adult mild-to-mo...
FDA accepts an AbbVie supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab (Rituxan) as a new treatment option for Waldenstrm's ma...
FDA clears a Zetta Medical Technologies 510(k) for its Zoom software, an MRI software algorithm for image quality enhancement and image optimization o...
Federal Register notice: FDA announces a 7/12 Antimicrobial Drugs Advisory Committee meeting to review a GlaxoSmithKline NDA.
FDA Review posts the Federal Register notices for the week ending 6/22/18.