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The following is a list of all entries tagged with drugs:
Drug Regulators, FDA, Publish Guidance For Industry on Content of a Compleate Submission for the Evaluation of Proprietary Names
Filed in manufacturing, marketing, February 17, 2010, 12:06 pmThis guidance describes for industry the information that FDA uses to evaluate proposed proprietary names for certain drugs, including biological products, under the traditional review process within the time frames set out in Prescription Drug User Fee Act (PDUFA IV) performance goals. The review clock for the performance review goals begins when the Agency receives a complete submission2 (see sections II. Background and III. PDUFA IV Goal Dates)
Drug Regulators, FDA- CDER, Publish Guidance on the Assessment of Abuse Potential of Drugs
Filed in clinical, licensing, marketing, February 7, 2010, 4:55 pmThis guidance is intended to assist sponsors who are developing drug products with the potential for abuse that may need to be scheduled under the Controlled Substances Act (21 U.S.C. 811(b), 811(c)).
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