US FDA updates guidance to speed up drug development

June 22 (Reuters) - The U.S. Food and Drug Administration said on Monday it is launching a series of measures to speed up drug research, from early-stage investigational studies to late-stage trials, ...
SGB Online

EXEC: Whoop Gets a Win for BPI Feature as FDA Officially Drops its Warning Letter

The U.S. Food and Drug Administration (FDA) has officially dropped its warning letter and enforcement complaint against Whoop ...
STAT

A former AI regulator, now in industry, says biopharma is reading FDA’s guidance wrong

Companies are being too conservative in how they interpret FDA's AI guidance, but the agency can do more to help, too, Tala ...
Food

FDA’s 2025 Food Agenda: What industry must know

FDA’s recently unveiled 2025 Human Foods Program guidance agenda offers a detailed view of the agency’s priorities for the year ahead. The document is non-binding, but provides critical insight into ...

From caffeine to 'healthy' labeling, FDA sets year-end agenda for US food supply

The U.S. Food and Drug Administration (FDA) has announced the food supply issues it seeks to tackle by year's end.
The Washington Post

FDA to issue new vaccine approval guidance amid questions over coronavirus shots

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump ...
RAPS

FDA drafts guidance on best practices for responding to inspection observations

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.
Medical Xpress

FDA releases guidance to promote nonopioid alternatives for chronic pain

The U.S. Food and Drug Administration released draft guidance to advance safe and effective nonopioid treatment options and reduce risks tied to prescription opioid misuse. "America's opioid crisis is ...
The American Journal of Managed Care

FDA Guidance to Remove One of the Largest Barriers to Biosimilar Development

The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...
The Manila Times

Memphis Surgeon Seeks to Overturn Conviction, Citing FDA Guidance on Medical Devices with National Experts Aghast at Overzealous Persecution Despite FDA Safe Harbor

Sworn Declarations from Former FDA Counsel and Renowned Device Regulation Expert Expose Clear Regulatory Carve-Outs for Outpatient Clinics; Emergency Motion Seeks to Strike Verdict Before July 7 Sente ...