FDA Related News

Human Drugs

Vanda, FDA Agree to Hetlioz Submissions

Vanda Pharmaceuticals says it has reached agreement with FDA to resubmit an NDA and supplemental NDA for Hetlioz (tasimelteon) for treating Smith-Mage...

Medical Devices

Philips Ultrasound Options Cleared for Covid-19

FDA clears a Royal Philips 510(k) for ultrasound options for managing Covid-19-related lung and cardiac complications.

Biologics

Sparrow Health Selling Unapproved Cell Products: CBER

A CBER notice of violation says Sparrow Health & Performance is providing unapproved adipose tissue-derived cellular products to treat many diseases a...

FDA Updates Covid Clinical Trial Guidance

FDA says it has updated the question-and-answer appendix in its guidance on conducting medical product clinical trials during the public health emerge...

Human Drugs

CDER Recommendations on IND Inquiries for Covid Drugs

CDER outlines recommendations for drug sponsors seeking product development inquiries for Covid-19 products.

Biologics

Moderna Covid-19 Vaccine Gets Fast Track

FDA grants Moderna a fast track designation for its mRNA vaccine candidate (mRNA-1273) for Covid-19.

Human Drugs

Multiple Violations at Nephron Pharmaceuticals

FDA releases an FDA-483 with nine observations from an inspection at Nephron Sterile Compounding Center.

Human Drugs

Court Backs FDA in PMRS Opioid Drug Case

The DC Circuit Court of Appeals says FDA acted properly in denying a PMRS NDA for an opioid product that claimed abuse-deterrent properties and reject...

Medical Devices

Applied Medical Python Embolectomy Recall Class 1

FDA says an Applied Medical recall of three embolectomy and cleaning catheters is Class 1.

Human Drugs

PhRMA Generally Supports Capacity Planning Method

PhRMA says it generally supports the FDA capacity planning adjustment methodology for drug and biologic user fee programs.