FDA Related News

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.

Combo Compliance Manual Includes Streamlined Approach

Hogan Lovells attorneys highlight the provisions in an updated compliance manual for CDER- and CDRH-led combination products.

Human Drugs

FDA Acceptance of Real-World Data for Drug Approval

Researchers from FDA and drug companies summarize FDAs acceptance of real-world data in drug approvals.

Human Drugs

OMB Reviewing FDA Cannabis Document: Report

Natural Products Insider says FDA has sent a CBD guidance document to the Office of Management and Budget for review.

Human Drugs

Progress Seen in Sex-Inclusive Research

Academic researchers find some progress made in sex-inclusive scientific studies but more needs to be accomplished.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes one medical product company chloroquineonline.com.

Human Drugs

FDA Walks Back CDER Testimony on API Volumes

FDA walks back misleading testimony by CDER deputy director Douglas Throckmorton who testified at a Senate Finance committee last week that the U.S. i...