FDA Related News

Human Drugs

FDA Awards 15 Clinical Research Grants for Rare Diseases

FDA awards 15 new clinical trial research grants totaling more than $22 million to advance product development for patients with rare diseases.

FDA General

Gottlieb Says FDA Working Daily on Puerto Rico Manufacturing Capacity

FDA continues working with Puerto Rico-based manufacturing facilities to restore their capacity in order to prevent possible medical product shortages...

Federal Register

Regulatory Review Period Determined for Impella 2.5 System

Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Abiomed Europes Impella 2.5 System.

Human Drugs

FDA Spent PDUFA Fees Appropriately: OIG

FDA has generally spent PDUFA user fee collections appropriately, according to an HHS Inspection General report.

Medical Devices

FDA Clears Nexxt Spine 3-D Printing for Interbody/Vertebral Devices

FDA clears a Nexxt Spine 510(k) for the Nexxt Matrixx System, 3-D printed porous titanium equipment for creating interbody and vertebral body replacem...

Noninferiority Trials Can Identify Innovations: Study

Harvard Medical School researchers suggest ways to improve noninferiority clinical trials.

Biologics

2017 CBER Recalls Up From 2016

A FY 2017 CBER recall posting report details an 11% increase in total recalls over FY 2016.

Human Drugs

ACLU Suit Challenges Mifeprex REMS

The ACLU files suit against FDA REMS restrictions on access to the Mifeprex abortion pill.

Human Drugs

Court Says Eye Drop Dispenser Suit Preempted

Attorney JP Ellison says a Massachusetts federal court ruled that suits challenging dispensers for prescription eye drops were preempted because the m...

Human Drugs

Jonca Bull Leaves FDA Again for PPD Consulting

FDA Office of Minority Health director Jonca Bull leaves FDA to join Pharmaceutical Product Development in a dual role as head of regulatory consultin...