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 ...
The Hill

FDA’s accelerated approval process is good enough for cancer and AIDS. Why not Alzheimer’s?

The U.S. Food and Drug Administration’s (FDA) approval of the first-ever disease-slowing therapy for Alzheimer’s has given hope to millions of Americans, their families, and caregivers who are all ...
PhillyVoiceOpinion

FDA's abrupt flip‑flop on Moderna's mRNA flu shot highlights growing risks to drugmakers of investing in vaccines

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.
MobiHealthNews

How the FDA process is biased against new technology

As FDA itself observes, “devices of a new type that FDA has not previously classified … are ‘automatically’ or ‘statutorily’ classified into class III…, regardless of the level of risk they pose.” To ...
Fox Business

Critics question Biden FDA's approval of COVID boosters for children: 'Slap in the face to science'

President Biden is yet again facing backlash over the FDA’s booster approval process, which recommended boosters for children this week without convening a panel of advisors to weigh in on the matter.

US FDA pushes for new methods to replace animal testing in early drug studies

March 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday issued a draft guidance to help companies reduce animal studies of experimental drugs and adopt newer methods, such as computer ...
The Baltimore Sun

FDA announces sweeping changes to speed up the drug review process

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
Agri-Pulse

FDA’s animal biotech regulatory process slows innovation

Washington State University fired up the grill for “CRISPR sausages” made with pork from gene-edited pigs. WSU is the first university to make meat from gene-edited livestock available for human ...
IFLScience

FDA Cleared Vs FDA Approved: What’s The Difference?

Holly has a degree in Medical Biochemistry from the University of Leicester. Her scientific interests include genomics, personalized medicine, and bioethics.View full profile Holly has a degree in ...
Forbes

Improving The FDA’s Regulatory Process Can Enhance Treatment Options

Peter Marks, director of Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research noted that “vaccination remains critical to public health and continued protection against ...
National Academies of Sciences%2c Engineering%2c and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...