FDA Approval Process - Search News

FDA moves to fast-track 3 psychedelic drugs for review

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 mushroom...

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FDA grants quick review for 3 psychedelic drug trials

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

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FDA moves to fast-track review of 3 psychedelic drug studies

The Food and Drug Administration (FDA) on Friday granted fast-track review to three companies studying psychedelic therapies to treat depression and post-traumatic stress disorder (PTSD), the latest s...

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Trump psychedelics order largely symbolic, analysts say

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FDA to speed up review of three psychedelics as mental health treatments

The FDA is psyched on psychedelics. Which ones will be studied and why?

After an executive order, the FDA announced it would prioritize the study of some psychedelic drugs for therapeutic use. Which did they choose and why?

PharmExec

The Long Wait for Rare Disease Treatment Approval: Q&A with Dr. Patricia E. Greenstein

FDA is formalizing RWD as core evidence, enabling “single pivotal trial plus confirmatory evidence” approaches that may obviate a second Phase 3 study in rare diseases. Methodological standards for RWD are tightening,

Indianapolis Business Journal

Complex process leads to a new drug’s identity

The laborious process of naming a pharmaceutical takes months and sometimes years of brainstorming, trademark review, legal analysis and regulatory compliance.

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 ...