FDA accepts for priority review an AstraZeneca supplemental NDA for Tagrisso (osimertinib) in combination with chemotherapy for treating certain adult...
FDA clears a SentiAR 510(k) for its CommandEP, which the company says integrates existing 3D cardiac mapping systems to create a real-time 3D holograp...
FDA updates its (XXX DELETE EXTRA SPACE XXX)Compliance Program Guidance Manual for the Inspection of Medical Device Manufacturers, Compliance Program ...
A new CDER Office of Generic Drugs pilot program to offer meeting opportunities to ANDA applicants who intend to use model-integrated evidence approac...
FDA approves a Pfizer NDA for Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate receptor modulator for adults with moderat...
Federal Register notice: FDA releases a draft guidance entitled Quality Considerations for Topical Ophthalmic Drug Products.
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Recall Regulations 21 CFR Part 7.
Federal Register notice: FDA sends to OMB an information collection extension entitled Importation of Prescription Drugs from Canada.
