RFK, Jr., puts psychedelics on fast track to FDA review and approval

On Friday the U.S. Food and Drug Administration announced it is fast-tracking the review and approval process for three companies studying psilocybin, the active psychedelic compound in magic
ABC7

FDA drug-approval processes analyzed in study

LOS ANGELES (KABC) -- The Food and Drug Administration's approval process is one of the most stringent in the world, but now some experts are questioning newer drugs that go through a quicker review. Before any medication reaches the drug store it's got to ...
Morning Overview on MSN

FDA moves to fast-track psychedelic drug reviews after Trump directive

The FDA announced on April 24, 2026, that it has granted a new class of accelerated review vouchers to three psychedelic drug programs, a move that could compress the agency’s standard 10- to 12-month review window to roughly one to two months once a company submits its final application.

FDA grants quick review for 3 psychedelic drug trials

FDA commissioner Marty Makary told NBC News that the first psychedelic drug could be approved in the U.S. as soon as this summer.

FDA moves to fast-track review of psilocybin and methylone for mental health

Some psychedelic drugs, once considered fringe, are now getting a step closer to possibly being approved for use as mental health treatments in the United States.
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 ...

The FDA just fast-tracked psychedelic drugs to treat depression. They could be here by this summer

The agency issued priority vouchers for 3 experimental new drugs using psilocybin and methylone, amid Trump’s pro-psychedelics push. The Trump administration is putting America on the fast track to a good trip.
RAPS

GDUFA II: FDA Looks to Speed Up Generic Drug Approval Process

On 21 October, the US Food and Drug Administration (FDA) will meet to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which FDA says it will begin offering eight-month and 10-month reviews of abbreviated new drug ...
The Hill

FDA to streamline approvals of generic biologic drugs

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The agency published a draft guidance for ...

FDA to expedite review process for psychedelic drugs following executive order

The FDA plans to expedite the review process for three psychedelic drugs aimed at treating mental health issues, following President Trump's executive order to enhance access to these treatments.