FDA grants Genentech a breakthrough therapy designation for Gazyva (obinutuzumab) for adults with lupus nephritis.
FDA grants Active Implants a breakthrough device designation for the NUsurface Meniscus Implant.
FDA clears a Viseon 510(k) for its Voyant System to integrate minimally invasive surgical access with real-time high definition imaging.
FDA releases its long-awaited Technology Modernization Action Plan that describes short-term actions it is taking to modernize technology use.
CDER issues a MAPP with policies and procedures for product development and pre-submission meetings with potential ANDA applicants.
FDA finalizes a guidance on drug-related citizen petitions and petitions for stay of action.
Federal Register notice: FDA seeks comments on an information collection extension for drug/biologic postmarketing studies status reports.
CDRH introduces its STeP safer technologies program.