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Federal Register

FDA Withdrawing Elancos Sulfamethazine

Federal Register notice: FDA withdraws approval of an Elanco new animal drug application for use of a prolonged-release bolus containing sulfamethazin...

OPDP Likely to Target Exhibit Booths: Attorney

Arnall Golden Gregory partner Alan Minsk predicts that CDER Office of Prescription Drug Promotion staff this year are likely to focus on materials dis...

Human Drugs

Clinical Sites Should Review Own Corrective Actions: FDA

FDA officials on a bioresearch monitoring Webinar offer good clinical practice recommendations to sponsors and clinical trial site operators to avoid ...

Medical Devices

FDA Urges Follow-up on Endovascular Aortic Repair

FDA sends a letter to healthcare professionals that emphasizes the importance of lifelong surveillance of patients with abdominal aortic aneurysm endo...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 2/25/2022.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 2/25/2022.

Human Drugs

FDA Revises AstraZenecas Evusheld Dosing

FDA revises an AstraZeneca emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab) to increase the initial dose for Covid-1...

Federal Register

FDA Amends Animal Drug Regs for Approvals

Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions for applications made during 7/2021, 8/2021 and...

Federal Register

FDA Withdrawing 5 No-Longer-Marketed ANDAs

Federal Register notice: FDA withdraws approval of five ANDAs from multiple applicants after they notified the agency that the drug products are no lo...