CDER Manual of Policies and Procedures (MAPPs) -

This site within CDER contains policies and procedures which must be applied by the agency in carrying out there responsibilities under the CFR and guidances and guidelines. Included in this category policy for having meetings with applications 

• Chapter 4500 - Training and Communications

• Formal Meetings Between CDER and CDER's External Constituents.

• Chapter 4700 - Compliance

• Drug Shortage Management - One element in the MAPP is for the Agency to use "regulatory discretion" as a way to alleviate or prevent a drug shortage.

• Chapter 6000 - Review Management

• Priority Review Policy 

• IND Process and Review Procdures 

• Refusal to Accept Applications for Filing from Applicants in Arrears 

• Chapter 7200 - Chemistry 

• Drug Application Approval 501(b) Policy 

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Bruce G. Berger
1559 Riverdale Drive
Oldsmar, FL 34677
Phone 813-786-3954.
Copyright © 1997 [CMC Applications]. All rights reserved.
Revised: April 03, 1997.