The DEA’s proposed rule says that the agency will only entertain abbreviated new drug applications, the process by which most generics are approved when the patent expires on a branded drug. That means requiring an organic dronabinol drug to mimic Marinol may actually help get an organic pill on the market in record time.
Payne declined to say when the rules would pass. ”There is no timetable for the publication of the final rule. As with all proposed rules, DEA is required by law to give careful consideration to the public comments in deciding whether to finalize the rule.”

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