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FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY

HUMAN DRUGS: INDEX PAGE

(Updated 06/06/2006)

Guide 1410.100

1410.101 Issuance of Notice Implementing the Provisions of the Drug Amendments of 1962

1410.102 Termination of Exemptions for New Drugs for Investigational Use in Human Beings

1410.103 Authority to Approve and to Withdraw Approval of a Charge for Investigational New Drugs

1410.104 Approval of New Drug Applications and Their Supplements

1410.105 Responses to Drug Enforcement Administration Temporary Scheduling Notices

1410.106 Issuance of Notices Relating to Proposals to Refuse Approval or to Withdraw Approval of New Drug Applications and Their Supplements

1410.107 Submission of and Effective Approval Dates for Abbreviated New Drug Applications and Certain New Drug Applications

1410.108 Extensions or Stays of Effective Dates for Compliance With Certain Labeling Requirements for Human Prescriptions Drugs

1410.109 Authority Relating to Waivers or Reductions of Prescription Drug User Fees

1410.110 Issuance of Written Notices Concerning Patent Information, Current Good Manufacturing Practices and False or Misleading Labeling of New Drugs

1410.111 Permit or Deny Use of an Investigational Drug for Treatment Use

Staff Manual Guides Table of Contents

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