BMJ

Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process

Introduction Transvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of ...
ebm.bmj

FDA approval of benzgalantamine exposes flaws in the 505(b)(2) pathway for innovations on existing drugs

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be ...
The Lancet

Predictors of withdrawal of anticancer drug indications granted accelerated approval: a retrospective cohort study

cOncology Department, Hospital de la Santa Creu i Sant Pau, Institut d’Investigació Biomèdica Sant Pau, Barcelona, Catalonia, Spain dDepartment of Medicine, Universitat Autònoma de Barcelona, ...
jnis.bmj

United States regulatory approval of medical devices used for endovascular neurosurgery: A two-decade review of FDA regulatory files

The FDA has a stated goal of 90 calendar days between regulatory submission to the determination of substantial equivalence for a 510 (k) filing. 12 Our findings indicate that before 2015, the average ...
Everyday Health

Dental & Oral Health

Oral health — taking care of your teeth and gums — is essential for keeping your mouth healthy and free of disease. Cavities, gum disease, and infections can all affect these areas. Maintaining good ...
Federal Register

Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; EYLEA HD (aflibercept)

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...
Health Affairs

Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals

After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the ...
BioSpace

FDA Approves Nalmefene HCl Injection, 2mg/2mL (1mg/1mL) for the Treatment of Known or Suspected Opioid Overdose with Natural or Synthetic Opioids

Purdue Pharma L.P. announced today that FDA has approved its abbreviated new drug application for Nalmefene hydrochloride injection, 2mg/2mL (1mg/1mL). STAMFORD, Conn.--(BUSINESS WIRE)-- Purdue Pharma ...