Zdrowie i gospodarka · 11.10.2011
Pilot Program To Evaluate Proposed Proprietary Name Submissions; Public Meeting on Pilot Program Results Will Not Be Held
The Food and Drug Administration (FDA) is announcing that it will not hold a public meeting to discuss the results of a 2-year voluntary pilot program that enabled participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated from those evaluations for FDA to review. FDA anticipated holding a public meeting at the end of fiscal year 2011 to discuss the results of the pilot program, but the Agency did not receive sufficient pilot submissions to form a basis for discussion. Interested parties may submit to the docket any additional comments on the pilot program. As previously announced, FDA plans to publish a draft guidance describing the best test methods for proprietary name evaluation.