FDA Related News

Human Drugs

More FDA Covid Transparency Needed: Professor

A University of Minnesota professor says FDA should be much more transparent about how its Coronavirus Treatment Acceleration Program works.

Human Drugs

AbbVie, Genmab Collaborate on Cancer Antibody Therapies

AbbVie and Genmab announce a collaboration agreement to jointly develop and commercialize three of Genmabs early-stage investigational bispecific anti...

Medical Devices

EUA for Covid Next-Generation Sequencing Test

FDA grants an emergency use authorization for the Illumina COVIDSeq test using next-generation sequencing technology.

Biologics

International Regulators Working on Covid Vaccine: Marks

CBER director Peter Marks says FDA is working with health regulators in other countries to reach broad agreement on parameters of clinical trials for ...

Medical Devices

New Rad Health Email Reporting Available

FDA says that all radiation safety reports may now be submitted to CDRH by email to the RadHealthCustomerService@fda.hhs.gov mailbox.

Medical Devices

Atomic Blue UV-C Germicidal Light Cleared

FDA clears an Atomic Blue 510(k) for its high-performance UV-C germicidal light for commercial use in eradicating the Covid-19 virus from surfaces.

Human Drugs

FDA Pilots Online Opioid Enforcement Route

FDA and the U.S. Commerce Departments National Telecommunications and Information Administration begin a 120-day pilot to help reduce unapproved opioi...

Human Drugs

FDA Collaboration on Real-world Datasets Post-Covid

FDA and HealthVerity enter into a multi-year research collaboration agreement to evaluate a range of different real-world datasets for their potential...

Web Site Warned on Chloroquinelone Sales

FDA warns a Web site operating at chloroquineonline.com that it is selling unapproved and misbranded drug products claiming to prevent, mitigate, or t...

Medical Devices

Sekisui Diagnostics Osom Ultra Plus Flu Test Cleared

FDA clears a Sekisui Diagnostics 510(k) for the Osom Ultra Plus Flu A&B Test.