FDA classifies as Class 1 a Philips Respironics recall of its continuous and non-continuous ventilators due to concerns about the polyester-based poly...
FDA approves AstraZenecas Bydureon and Bydureon BCise (exenatide extended-release) injection for use in addition to diet and exercise to improve glyce...
Federal Register notice: FDA sends to OMB an information collection extension entitled Prescription Drug Advertising--21 CFR Part 202.
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Product Communications That Are Consistent With the FDA...
Federal Register notice: FDA announces the generic animal user fee rates and payment procedures for fiscal year 2022.
Greenleaf Health adds former FDAers Julia Barrett, Chris Leptak, and Grace McNally to its regulatory consulting staff.
FDA says it will not meet the already-extended PDUFA action dates for Pfizer submissions for abrocitinib and Xeljanz.
FDA says it is soliciting applications for new Patient Engagement Collaborative members.