Federal Register notice: FDA determines that Sandozs Zofran ODT (ondansetron) orally disintegrating tablets (4mg and 8mg) were not withdrawn due to sa...
Aldeyra Therapeutics says it is addressing substantive late review-cycle concerns raised by FDA on the companys NDA for reproxalap for treating dry ey...
An FDA update says GE HealthCare preliminary testing on its newly manufactured neonatal incubators suggests they may have higher levels of formaldehyd...
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...
