FDA Related News

Human Drugs

Accelerated Approval Guide Pushes Randomized Trials

Pushing randomized clinical trials, FDA issues a draft guidance entitled Clinical Trial Considerations to Support Accelerated Approval of Oncology The...

Federal Register

CDER/CBER Digital Health Framework

Federal Register notice: FDA releases CDER/CBERs Framework for the Use of Digital Health Technologies in Drug and Biological Product Development.

Biologics

Cell/Gene Therapy Post-approval Data Meeting

CBER's Office of Therapeutic Products plans a 4/27 public listening meeting to obtain feedback on methods and approaches for capturing post-approval s...

FDA Keeping Close Eye on Social Media Promotion

CDER's Office of Prescription Drug Promotion (OPDP) says it is monitoring very closely the increasing use of social media platforms that promote presc...

Medical Devices

New CDRH Web Page on Diagnostic Data Program

CDRH launches a new Web page to discuss mission-critical priorities of data and technology innovations and provide information and resources on its Di...

Medical Devices

Getinge PMA Approved for Iliac Artery Stent

FDA approves a Getinge PMA for its iCast covered stent system for treating patients with iliac arterial occlusive disease.

Human Drugs

Dose Optimization Info for Combo Drugs Needed: PhRMA

Pharmaceutical Research and Manufacturers of America says a recent FDA draft guidance on oncologic drug development provides limited information on ho...

Human Drugs

Incyte Complete Response on Once-daily Jakafi

FDA issues Incyte a complete response letter for Jakafi (ruxolitinib) extended-release tablets, a JAK1/JAK2 inhibitor for once-daily use in treating c...

Federal Register

Comments Sought on REMS Modification Requests

Federal Register notice: FDA establishes a docket to solicit comments on factors that should be considered when reviewing risk evaluation and mitigati...

Human Drugs

Panel Backs Accelerated OK Consideration of Biogen's ALS Drug

An FDA advisory committee votes 9 to 0 that Biogens amyotrophic lateral sclerosis drug tofersen should be considered for accelerated approval.