Agri-Pulse

FDA looking at animal food ingredient approval process

The Food and Drug Administration is seeking comments on how to handle approval of animal food ingredients following last week’s announcement it will not be renewing a memorandum of understanding with ...
Medscape

FDA Tightens Approval Process for Radiotherapy Devices

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...
Nasdaq

ADMA Biologics Receives FDA Approval for Innovative Yield Enhancement Process, Paving the Way for Increased Production Capacity and Revenue Growth

ADMA Biologics receives FDA approval for a process enhancing plasma production yields by 20%, boosting growth and capacity for its products. ADMA Biologics, Inc. has announced the U.S. FDA approval of ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
KETV Omaha

FDA official plans to change vaccine approval process

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...
PBS

One medical device is raising questions about FDA’s approval process

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...
Seeking Alpha

ADMA Biologics Announces U.S. FDA Approval of Innovative Production Yield Enhancement Process

This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. (“we,” “our” or the ...
WESH

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
FiercePharma

FDA misses another approval decision target date, this time for GSK's Nucala in COPD

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA nod ...