Medscape1 天
The Approval of Mifepristone (RU486) in the United States: What's Wrong With this Picture?
As long as social conservatives remain in power, review and approval process at the FDA will continue to come under heavy partisan scrutiny. Allowing decisions about medical science to be delayed ...
FDA expands drug access with self-screening rule
Rule could make more medications available over the counter through a process called Additional Condition of Non-prescription ...
GlobalData on MSN10 天
FDA grants pre-market approval to HLB Life Science’s disposable syringe
The US Food and Drug Administration (FDA) has granted pre-market approval (510K) to HLB Life Science’s Sofject disposable ...
FDA 510(K) Approved Facilities: Increasing GMP Inspections And Compliance Requirements
Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA ...
JD Supra3 天
FDA issues Guidance on Interim Animal Food Ingredient Consultation (AFIC) Process
Center for Veterinary Medicine (CVM) issued its final guidance on the interim Animal Food Ingredient Consultation (AFIC) process, which FDA positions as a stopgap measure to temporarily replace FDA’s ...
NBC Washington5 天
Healthy Returns: The FDA approved fewer new drugs in 2024 — but some big ones hit the market
The agency handed the first approval to a drug called Miplyffa from Zevra Therapeutics, which reached the finish line on the second try after a prior rejection in 2021. Privately-held IntraBio's ...
The Australian7 天
FDA pre-approval inspection of EBR’s WiSE CRT system set for early January
The key milestone follows the FDA’s start of its substantive review process of EBR’s pre-market approval (PMA) submission for its WiSE CRT (cardiac resynchronisation therapy) System in late ...
Yahoo Finance11 天
ANI Pharmaceuticals Announces the FDA Approval and Launch of Prucalopride Tablets with 180 ...
(ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company has ...