Several stakeholders comment on an FDA reorganization plan for the Office of New Drugs intended to speed and facilitate drug development.
FDA asks for medical device industry cooperation with onsite verification of facility information provided to the agency.
Federal Register notice: FDA makes available a final guidance entitled Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Othe...
Federal Register notice: FDA seeks comments on an information collection extension for Index of Legally Marketed Unapproved New Animal Drugs for Minor...
A CDER report on 2019 novel drug approvals shows that 60% of the 48 drugs approved came under at least one expedited development and review method and...
Stakeholders look for ways to improve meaningful communication between the Office of New Drugs and stakeholders involved in drug development.
The FY 2019 report issued by CBER director Peter Marks touts several different types of drug and vaccine approvals.
FDA clears an IceCure Medical 510(k) for its Cryoablation Technology and its use to destroy benign and cancerous tumors by freezing them.