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FDA’s Office of Pharmaceutical Quality (OPQ) has developed a manual of policies and procedures (MAPP) detailing how to submit grouped product quality supplements that provide for the same CMC changes to multiple approved NDAs, ANDAs, and BLAs, when submitted by the same applicant. The goal, OPQ stated, is to improve the efficiency and consistency of the review process. The policies and procedures were enacted in mid-April.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
