Federal Register notice: FDA updates its listing of guidance documents related to the Covid-19 public health emergency.
FDA approves AbbVies Dalvance (dalbavancin) for treating acute bacterial skin and skin structure infections in pediatric patients.
Federal Register notice: FDA seeks comments about abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on ...
Federal Register notice: FDA makes available a final guidance entitled Field Alert Report Submission: Questions and Answers.
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...