October 17, 2014 at 02:57PM FDA Issues Draft Guidance with Recommendations for Drug Sponsors Submitting Two-Phased Chemistry, Manufacturing, and Controls Technical Data

The U.S. Food and Drug Administration issued today draft Guidance for Industry #227: Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections, with recommendations for ways animal drug sponsors can submit chemistry, manufacturing, and controls (CMC) data to the agency to improve the efficiency of the New Animal Drug Application (NADA) review process.



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