FDA Related News

Medical Devices

CDRH Wants Proposals on Device Learning Site Visits

CDRH seeks proposals for medical device site visits as part of its Experiential Learning Program, which is intended to educate the Center on how new t...

Human Drugs

Former FDAer Joins Sidley

Former CDER combination product team leader Jay Jariwala joins the Sidley law firm.

Human Drugs

Keytruda, Lenvima Flunk uHCC Trial

Merck and Eisai say the combination of Keytruda and Lenvima failed to meet two primary endpoints in a test of patients with unresectable hepatocellula...

Resume User Fee Talks: Disease Interests

Some 99 health-related advocacy and service groups call on Congress to resume consensus talks on user fee reauthorization legislation.

Human Drugs

Pfizer Ditches Cardiomyopathy Drug After Trial Miss

Pfizer discontinues developing PF-07265803 in patients with symptomatic dilated cardiomyopathy after an interim futility analysis of the global Phase ...

Human Drugs

Regenxbio to File BLA for Hunter Syndrome Treatment

Regenxbio plans a BLA using the accelerated approval pathway for its RGX-121 Hunter Syndrome treatment.

Human Drugs

Aurobindo Hit with FDA-483 After Inspection

FDA issues a Form FDA-483 to Aurobindo Pharma, citing three observations after investigators inspected the firms Unit XI, an active pharmaceutical ing...

Human Drugs

Humira Patent Thicket Case Dismissal Affirmed

The 7th Circuit Court of Appeals affirms a lower court decision dismissing a suit charging that AbbVies filing of 132 additional Humira patents violat...

Federal Register

FDA Seeks Comments on Scheduling Changes for 10 Drugs

Federal Register notice: FDA seeks comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling change...

FDA General

Woodcock Outlines IT Transformation at FDA

Speaking at an Alliance for a Stronger FDA Webcast, FDA principal deputy commissioner Janet Woodcock says FDA is working toward new efficiencies throu...