FDA Approval Process - Search News

FDA advisers back first of seven peptides under review

FDA advisers say six popular peptides can be compounded. Here are the issues they considered

A group of experts, some of whom work in the peptide industry, said the Food and Drug Administration should allow six peptides to be compounded, in a move that could widen access to the popular wellness products for Americans.

MSN · 5h

FDA advisers recommend relaxing US rules on compounding peptides

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FDA advisory panel recommends loosening restrictions on 2 unapproved peptides

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FDA advisers back first of seven peptides under review for looser rules

A majority of the U.S. Food and Drug Administration's panel of outside advisers on Thursday voted to allow pharmacies to compound the first of seven in its review of widely used peptides, the ‌increa...

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FDA panel recommends controversial treatments

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Telehealth Firms Urge FDA to Legalize Peptides

1don MSN

An FDA Committee Just Voted in Favor of Peptides—Despite the Agency's Opposition

The group met on July 24 to vote on whether compounding pharmacies could legally dispense certain peptides.

Food Processing

New Details Emerge on FDA's GRAS Rulemaking

Although Secretary Kennedy promised it months ago, a new rule for the Generally Recognized as Safe process is scheduled to be released by the end of this year.

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 genetic defects will receive assurance of agency ...

9don MSNOpinion

FDA drug approval affects healthcare around the world, but political shortcuts could hurt the agency’s international reputation

At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with sickle cell disease. While this is good news for children in the U.S. born with this illness,

RAPS

Tougher FDA Approval Process for Opioids Sought by Congress

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). The bill, the FDA Accountability for Public Safety Act (FAPSA ...

STAT

U.S. health officials inject new uncertainty into approval process for Covid boosters

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on Signal at hbranswell.01. Confusion over the Food and Drug ...

CNN

With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be included in this year’s Covid-19 vaccines, giving the ...

RAPS

New FDA Guidance Explains Process Behind Safety Labeling Changes for Drugs, Biologics

The US Food and Drug Administration (FDA) has released a new guidance document pertaining to labeling changes made to pharmaceutical and biological products based on new safety information discovered after initial FDA approval, including the process of ...

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 accelerators that they can no longer count on winning ...

The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay Prasad, MD, MPH, announced in a commentary published in ...