Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 1/21/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 1/21/2022.
Federal Register
FDA Seeks Comments on Covid Guidances
Federal Register notice: FDA announces recent guidance documents related to the Covid-19 public health emergency.
Federal Register
Draft Guide on 702(b) FDA Samples
Federal Register notice: FDA makes available a draft guidance entitled Collecting and Providing 702(b) Portions of FDA Official Samples Questions and...
Federal Register
FDA Revokes 5 Covid Test EUAs
Federal Register notice: FDA revokes the Emergency Use Authorizations for five Covid tests because they are no longer marketed, distributed or support...
Human Drugs
Guide on Technical Specs for NASH Drug Data Sets
FDA posts a revised guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Stea...
Medical Devices
Medtronic Recalls HawkOne Atherectomy System
Medtronic recalls its HawkOne Directional Atherectomy System due to the risk of the guidewire within the catheter moving downward or prolapsing when f...
Human Drugs
FDA Lifts Hold on Kura Leukemia Trial
FDA lifts a partial clinical hold on a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory acute myeloid leukem...
Human Drugs
Pazdur Mulls Accelerated Approval International Harmonization
FDA Oncology Center of Excellence director Richard Pazdur suggests changes to the agencys accelerated approval program, such as international harmoniz...
