FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
FDA General

Republicans Dismiss RFK Jr. Subpoena Vote for Testimony

House Energy and Commerce Committee Republicans blocked an effort by Democrats to compel HHS secretary Robert F. Kennedy Jr. to testify before Congres...

Biologics

Sen. Johnson Seeks FDA Docs on Covid Vaccine Deaths

Sen. Ron Johnson (R-WI) demands that FDA turn over records related to an internal review that linked Covid-19 vaccinations to the deaths of at least 1...

latest-news-card-1
Medical Devices

Medical Device RWE Guidance

FDA publishes a guidance clarifying how it evaluates real-world data to determine if they are sufficient to provide real-world evidence for regulatory...

latest-news-card-1
Human Drugs

Merck Cholesterol, Cancer Drugs Added to Voucher Program

FDA selects investigational cholesterol and cancer drugs from Merck for expedited regulatory reviews under its Commissioner's National Priority Vouche...

latest-news-card-1
Human Drugs

3D Imaging CGMP and Listing Violations

FDA warns Little Rock, AR-based 3D Imaging Drug Design and Development about CGMP and listing violations in its production of positron emission tomogr...

latest-news-card-1
Human Drugs

FDA Extends Review Timeline for Aldeyras Dry Eye Drug

FDA extends the review of Aldeyra Therapeutics NDA resubmission for reproxalap, pushing back a regulatory decision on the investigational dry eye dise...

latest-news-card-1

Guide to Increase Female Enrollment in Trials

FDA publishes a draft guidance aimed at increasing the enrollment of females in clinical trials of drugs and medical devices.

latest-news-card-1
Human Drugs

Trump Taps Controversial Figure to Lead Cancer Panel

President Trump appoints Yale epidemiologist Harvey Risch to chair the Presidents Cancer Panel, a move that is raising alarm among cancer researchers ...

latest-news-card-1
Human Drugs

7 Observations on ProRx FDA-483

FDA releases the form FDA-483 with seven observations from an inspection at the Exton, PA-based ProRx outsourcing facility.

latest-news-card-1

Microvascular Tissue Marketing Unapproved New Drug

FDA warns San Diego, CA-based Microvascular Tissue about CGMP violations in its production and marketing of an unapproved new drug that is also an unl...