Manual of Policies and Procedures MAPP Drug Shortage Management Drug Shortage Management FDA/CDER/An

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Specifications	Manual of Policies and Procedures MAPP Drug Shortage Management Drug Shortage Management FDA/CDER/Andy.Nguyen
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MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 6003.1 POLICY AND PROCEDURES OFFICE OF NEW DRU

Specifications	Manual of Policies and Procedures MAPP Drug Shortage Management Drug Shortage Management FDA/CDER/Andy.Nguyen
Outline	PURPOSE BACKGROUND POLICY RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE ATTACHMENT 1 ATTACHMENT B RESPONSIBILITIES AND PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE
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Content	MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 6003.1 POLICY AND PROCEDURES OFFICE OF NEW DRUGS Drug Shortage Management Table of Contents PURPOSE.1 BACKGROUND.1 POLICY.2 RESPONSIBILITIES AND PROCEDURES.3 REFERENCES. 7 7 8 DEFINITIONS. EFFECTIVE DATE. ATTACHMENT 1.9 ATTACHMENT B.18 PURPOSE • This MAPP establishes the Center for Drug Evaluation and Research (CDER) procedures for notification, evaluation, and management of drug shortage situations for all CDER products (e.g., investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and critical products from any source). • This MAPP also establishes the CDER Drug Shortage Program (DSP). BACKGROUND In recent years, the number, sources, and complexity of drug shortages have grown. The need to expand and enhance the management of shortage situations across the Center resulted in the formal establishment of the DSP. The DSP serves as the focal point for the evaluation and management of CDER drug shortage situations in support of the FDA’s mission. Through communication, facilitation, and negotiation, the DSP works with internal and external stakeholders to prevent, alleviate, and resolve shortage situations Originating Office: Office of Antimicrobial Products Effective Date: 09/28/06; 02/03/12 Page 1 of 21
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Manual of Policies and Procedures MAPP Drug Shortage Management Drug Shortage Management FDA/CDER/Andy.Nguyen

Manual of Policies and Procedures MAPP Drug Shortage Management Drug Shortage Management FDA/CDER/Andy.Nguyen