• Introduction
  • Deleted references to paper copies. The March 2009 edition is only available on the internet.
• Chapter 1 - Regulatory Organization
  • Reflects organizational changes in CBER and CDER, and adds new phone numbers for CDER.
• Chapter 4 - Advisory Actions
  • 4-1-4 Center Concurrence and Letters Issued by Centers – Updates CDER phone numbers.
  • 4-1-7 Time Frames – Asks that Warning Letter disapproval memos be provided to HFC-240.
  • 4-1-9 Firm Profile Updates in FACTS – Provides additional and updated information.
  • 4-1-11 Warning Letter Distribution and 4-1-13 Freedom of Information (FOI) - Reflects new procedures for sending Warning Letters to Division of Freedom of Information via the MARCS-CMS system; and eliminates the requirement to provide copies of Warning Letters to ORA HQ, Center compliance units, and district offices.
  • 4-1-15 (CDER) – Deletes a reference to a center jurisdiction change; acknowledges that a preapproval inspection may result in a recommendation concerning marketed, approved drugs; establishes a practice for the submission of regulatory action recommendations; and updates contact information.
  • 4-1-18 Tracking (WLs) and 4-2-2 Tracking (ULs), and Ex. 4-1 Procedures for Clearing FDA Warning Letters and Untitled Letters – Adds a reminder to update a firm's profile status information in FACTS.
  • 4-2 Untitled Letters - Requires center concurrence for Untitled Letters in the areas listed in section 4-1-4 (Warning Letters requiring center concurrence).
• Chapter 5 - Administrative Actions
  • NOTE: - Adds reminder to update a firm's profile status information in FACTS.
  • 5-6-2 General (License Revocation or Suspension) – Refers to SMG 1410.203.
  • 5-8-1 Civil Money Penalty Authorities – Includes new authorities provided by FDAAA.
• Chapter 6 - Judicial Actions
  • NOTE: - Adds reminder to update a firm's profile status information in FACTS.
• Chapter 8 - Emergency Procedures
  • 8-2-1 Policy – Updates description of Emergency Operations Center (EOC) activities.
  • 8-4-1 Alert – Adds "4.Confirmation of declaration of pandemic influenza…”
  • 8-4-2 Presumptive – Adds "6.Confirmation of widespread outbreak in multiple locations overseas…”
  • 8-4-3 Confirmed – Adds "The first human case of pandemic influenza in U.S. is confirmed…”
  • 8-5-2 Emergency Alerts - Adds "pandemic influenza."
  • 8-6-1 FDA Emergency Operations Center, 2. EOC 24 Hour Telephone Contacts – Updates procedure.
  • 8-5-4 Emergency Management – Includes “managing on-scene operations.”
  • 8-5-5 Reporting 2. Hard Copy Reports - Updates addresses.
  • Various - Updates mail and e-mail addresses and includes minor editorial changes.
  • Deletes Exhibit 8-1 – FDA/CDC MOU.
• Chapter 10 - Other Procedures
  • 10-1-1 Regulatory Actions that Require Center Concurrence – Adds reminder to update FACTS.
  • Section 10-5 Establishment Inspection Report (EIR) Conclusions and Decisions – Adds reminder to update FACTS.

Chapter 5 of Regulatory Procedures Manual (RPM) was updated as detailed below.

• Chapter 5 - Administrative Actions
  • Chapter 5 was revised to add new Section 5-9 - Disqualification of Clinical Investigators