- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
MMJ BioPharma is seeking FDA approval for its clinical trials, facing regulatory requirements under the Administrative Procedure Act and demands from DEA Administrator Cole.
1 report, 1 independent
Updated Sep 4
AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.
What happened
MMJ BioPharma is seeking FDA approval for its clinical trials, facing regulatory requirements under the Administrative Procedure Act and demands from DEA Administrator Cole.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- MMJ International Holdings is pursuing pharmaceutical development under FDA oversight, with its activities framed by the Controlled Substances Act.Sub-event
MMJ seeks FDA approval for clinical trials while navigating APA requirements and demands from DEA Administrator Cole.1 source
Keep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- A partnership with BARDA has accelerated the development of SCY-247 for the company.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
Related events
- Litigation regarding FDA approval process.
- FDA provided guidance for HCW Biologics' IND application.
- FDA removed the clinical hold on Arbutus Biopharma Corporation's IND application, allowing potential clinical development.
- Marty Makary serves as FDA Commissioner overseeing drug approvals and advocates for psychedelic therapies in clinical settings.
- The DEA opposed a motion before Chief Administrative Law Judge Julius, noting that both agencies lack comprehensive scheduling policies.
Coverage
Newest first; wire copies grouped- ACCESS NewswireDEA Marijuana Decision Showtime: MMJ Issues Demand Letter on DEA Duane Boise stated "In a September 3rd letter to DEA Terry Cole, that the Administrative Procedure Act requires agencies to act "withi