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Vaporox Next-gen Wound Healer Cleared

[ Price : $8.95]

FDA clears a Vaporox 510(k) for its next-generation VHT-200 medical device system for healing chronic wounds.

Iovance Biotherapeutics BLA for Melanoma Therapy

[ Price : $8.95]

Iovance Biotherapeutics files a rolling BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating certai...

Draft Guide on Cancer Drug Accelerated Approvals

[ Price : $8.95]

Federal Register notice: FDA posts a draft guidance entitled Clinical Trial Considerations to Support Accelerated Approval of Onco...

OTC Monograph Drug User Fee Rates

[ Price : $8.95]

Federal Register notice: FDA announces the fee rates under the over-the-counter monograph drug user fee program for fiscal year 20...

Two Final Guides on Covid-19 Device Transition

[ Price : $8.95]

FDA issues two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizat...

Accelerated Approval Guide Pushes Randomized Trials

[ Price : $8.95]

Pushing randomized clinical trials, FDA issues a draft guidance entitled Clinical Trial Considerations to Support Accelerated Appr...

CDER/CBER Digital Health Framework

[ Price : $8.95]

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

Cell/Gene Therapy Post-approval Data Meeting

[ Price : $8.95]

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

FDA Keeping Close Eye on Social Media Promotion

[ Price : $8.95]

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

New CDRH Web Page on Diagnostic Data Program

[ Price : $8.95]

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