September FDA news in review

fda.sp.png

Welcome to the first installment of "FDA News in Review," where each month we'll take a look at the agency's latest decision, approvals, warnings and recalls. We hope this feature will help you keep up on FDA trends--and catch up on stories you may have missed.

One of the top stories out of the FDA this month was the agency's push to fill 1,300 new positions. The new hires include chemists, biologists and microbiologists, many of whom will be assigned to the CDER. Overall, the agency is increasing its workforce by about 10 percent. And while the FDA was light on approvals this month, it was certainly busy monitoring drug safety. The agency announced that it will now release a quarterly list of drugs under investigation due to adverse events. The nature of the complaints will be included in the report, but the number of complaints won't be.

What's new at the FDA

  • FDA on hiring binge to fill research ranks
  • FDA staffing push yields 1,300 hires
  • Waxman attacks FDA preemption rule
  • Biotech animals focus of regulatory review

FDA Approvals

  • Nasacort approved in 2- to 5-year-olds
  • Three new therapies approved by the FDA
  • FDA grants Gardasil two new indications


FDA Decisions

  • FDA again delays prasugrel decision
  • Panel backs Pfizer's Fablyn, with caution
  • Introgen shares plunge on BLA rejection
  • FDA delays Roche's blockbuster Actemra

Safety, Warnings & Recalls

  • FDA names 20 drugs in safety probes
  • Tarceva linked with two patient deaths
  • FDA halts Ranbaxy India imports
  • FDA orders tougher warnings on TNF drugs


September FDA news in review
Read more on

Suggested Articles

The efficacy between Keytruda and FerGene's nadofaragene firadenovec look comparable in their studies, though Merck has at least one upper hand.

Thursday, the FDA approved the first three generic versions of Gilenya, but they may not hit the market anytime soon due to ongoing litigation.

Gilead is hoping to score a patent extension on TAF meds, but patient advocates say that would reward conduct that harmed patients.