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Marketing

Healthcare Providers Value Reprints: Report

A CMI Media doctor survey shows that providers want to receive current medical news and clinical information and can access a variety of media.

Federal Register

Annual Report on Postmarketing Requirements

Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...

Federal Register

FDA Revokes Emergency Use OK for Zika Test

Federal Register notice: FDA revokes an Emergency Use Authorization issued to InBios International for the ZIKV Detect 2.0 IgM Capture ELISA test.

Federal Register

Annual Report on Closed Advisory Panel Meetings

Federal Register notice: FDA releases an annual report on agency advisory committees that held closed meetings during fiscal year 2018.

Medical Devices

FDA Warns on Paclitaxel-coated Devices Mortality Signal

In an 8/7 letter to physicians, FDA says updates to device labeling and clinical trial informed consent documents are coming because of ongoing concer...

Human Drugs

FDA Funding Rare Disease Data Platform Meeting

FDA funds a meeting to launch a new rare disease data analytics platform.

Medical Devices

NvisionVLE Imaging System OKd for Pancreas/Bile Duct

FDA clears a NinePoint Medical for the NvisionVLE Imaging System for use in the pancreas and bile duct.

Human Drugs

FDA Should Address Approval Rate Factors: GAO

The Government Accountability Office suggests ways in which FDA could address factors that restrict generic drug first review cycle approvals.

Human Drugs

Blueprint NDA Gets Priority Review for Avapritinib

FDA accepts for priority review a Blueprint Medicines NDA for avapritinib for treating adult patients with PDGFRA Exon 18 mutant gastrointestinal stro...

Medical Devices

FDA Seeks Computational Heart Modeling Software

FDA looks for potential vendors to perform whole heart simulations and studies.