We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A ranking Democratic congressman has asked the FDA to immediately release summaries of studies on pediatric use of antidepressants and other drugs that the agency has withheld to date.
The FDA is withdrawing six guidances on the clinical evaluation or approval requirements for six classes of drugs because they are out of date and of little value to the industry, the agency announced yesterday.
The FDA intends to discontinue the use of approvable letters and not-approvable letters for drug marketing applications and instead use “complete response letters” to indicate the review cycle is complete but the application is not ready for approval, the agency announced yesterday.
The FDA should abbreviate or even withdraw 21 CFR Part 11 and instead rely on legislative measures passed by Congress to craft policy defining how drugmakers use erecords and esignatures in drug applications, biologics license submissions and other filings with the agency, according to a drug industry trade group.
With an eye toward getting more cancer drugs on the market, the FDA has announced it will consolidate and restructure its divisions responsible for cancer drugs and therapeutic biologics.
The FDA accused Spinal Concepts of failing to validate materials and design changes on its vertebral replacement devices, violating the agency’s Quality System regulations (QSR), according to a June 21 warning letter.