Federal Register notice: FDA makes available a draft guidance on Best Practices for Convening a GRAS Panel.
The Government Accountability Office says FDA has properly implemented the 2014 Sunscreen Innovation Act in the time frames set by the legislation.
FDA approves Genentechs Hemlibra for preventing or reducing the frequency of bleeding episodes in those with hemophilia A.
FDA approves Pfizers Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer returning after a ...
FDA accepts an Alkermes NDA for aripiprazole lauroxil nanocrystal dispersion (ALNCD) as an add on therapy with its Aristada (aripiprazole lauroxil) ex...
Former CDER Office of Process & Facilities director Robert Iser joins Parexel as vice president of regulatory consulting services.
Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.
FDA clears a Voluntis 510(k) for Insulia, a digital companion for people with Type 2 diabetes that the company says can integrate Lillys Basaglar and ...