Federal Register notice: FDA posts a draft guidance entitled Safer Technologies Program for Medical Devices, a new, voluntary program for certain devi...
Federal Register notice: FDA makes available a final guidance entitled Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of...
FDA updates its list of drugs for which the agency has received a reference-listed drug access inquiry.
House Speaker Nancy Pelosi releases her initial legislation to lower drug prices in ways she hopes will attract support from President Trump.
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 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.