- 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
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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
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- 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.
- The FDA is accused of failing to enforce safety regulations and operating under current rules without in-person oversight.
- FDA rule changes are causing delays in product approval, leading to the process exceeding Congressional mandated timeframes.
- The FDA is facing public scrutiny due to oversight failures, leading to the introduction of new legislation targeting agency shortcomings.
- Former FDA administrator Marty Makary is involved in events where FDA actions are questioned, monitored by Nassau County legislature, and Judy Jacobs is present.
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