FDA to review whether to allow more access to certain peptides

The U.S. Food and Drug Administration (FDA) will soon review whether certain peptides should be allowed in customized ...

RFK Jr. Pushes To Expand Access To Peptides. A Doctor Explains The Risks

A physician examines whether the FDA's loosening of wellness peptide restrictions means these compounds are actually safe and ...

FDA to weigh easing limits on unproven peptides favored by RFK Jr. and other MAHA figures

Federal health officials will meet in July to weigh easing limits on a group of drugs popular with Robert F. Kennedy Jr.'s ...
BioSpace

FDA Blueprint Aims To Cut Regulatory Risk for Alternatives to Animal Testing

Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing ...
Newsweek

Moms Stage ‘Funeral’ Outside FDA in Drug Protest

Prefer Newsweek on Google to see more of our trusted coverage when you search. More than 100 mothers and advocates affected by a type of rare disease gathered outside the Food and Drug Administration ...
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 ...
CNN

FDA goes on offense amid surge of criticism for recent drug decisions

In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug Administration held a call with reporters Thursday to defend the agency’s recent ...
The New York Times

F.D.A. Faces Upset Over Denials of New Drugs

Agency officials promise fast reviews of new treatments while vowing they will not be a “rubber stamp” for the industry. But patients with rare diseases view recent decisions as signs that the doors ...
RAPS

FDA drafts guidance explaining 3-year clinical investigation exclusivity for new drugs

In a new draft guidance, the US Food and Drug Administration (FDA) has provided details on the clinical investigation requirements that sponsors of new drugs must meet to obtain three years of ...
Reuters

US FDA warns Novo again about misleading drug advertising

March 3 (Reuters) - The U.S. Food and Drug Administration has warned Novo Nordisk (NOVOb.CO), opens new tab over a consumer ad for its blockbuster diabetes drug, Ozempic, saying the commercial makes ...
Futurism

Government Handing Out Cash Bonuses to Drug Researchers Who Rush Through Regulatory Approvals

Add Futurism (opens in a new tab) Adding us as a Preferred Source in Google by using this link indicates that you would like to see more of our content in Google News results. Not even a year after ...
FierceBiotech

'Like talking to a brick wall': Senate hearing takes aim at FDA's rare disease review process

A panel of physicians, biotech leaders and patient advocates took aim at the FDA during a Senate hearing Thursday on how the agency’s bureaucracy affects innovation, with one witness testifying that ...