Extent Of DXM Abuse May Not Support Scheduling
Dextromethorphan abuse is increasing slightly, but the problem is not widespread, according to FDA. One expert notes the extent might not justify scheduling the cough suppressant as a controlled substance
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The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.
A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.
The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.