Office of Drug Safety

Regulations, Guidances and MaPPs

• Federal Regulations

• Guidances

• Manual of Policies and Procedures (MaPPs)

• Electronic Submission of Postmarketing Expedited Safety Reports.

Federal Regulations

• The Federal Food, Drug, and Cosmetic Act,  Chapter V, Drugs and Devices.  The Federal Food, Drug, and Cosmetic Act (the Act), was signed into law in 1938 and has been amended several times since; enforcement accounts for about 90 percent of FDA's workload. This statue and its amendments provide for the regulation of foods, human and animal drugs, medicated animal feeds, medical devices, and cosmetics.

• 21 Code of Federal Regulations
  •  21 Code of Federal Regulations Section 310.305.   This section of the code is titled; "Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications."  It addresses the type of reports that are required to be submitted to the Agency (FDA) when an adverse reaction occurs with a drug that is not required to have an NDA (pre-1938 marketed drugs).
  • 21 Code of Federal Regulations Section 314.80.  This section of the code is titled; "Postmarketing reporting of adverse drug experiences."  It addresses the type of reports that are required to be submitted to the Agency (FDA) when an adverse reaction occurs with a drug that is marketed under an approved New Drug Application.
  • 21 Code of Federal Regulations Section 314.90.  This section of the code is titled  "Applications for FDA approval to market a new drug: Waivers," and addresses waivers to requirements under Section 314.50 through 314.81.  
  • 21 Code of Federal Regulations Section 314.98. This section of the code is titled, "Postmarketing Reports." It addresses the requirements regarding the reporting and recordkeeping of adverse drug experiences for abbreviated new drug applications.
  • 21 Code of Federal Regulations, Section 201.10(c).  This section of the code is titled "Labeling: Drugs; statement of ingredients," and addresses some reasons the labeling of a drug may be misleading.
  • 21 Code of Federal Regulations Part 208. This part of the code is titled, "Medication Guides for Prescription Drug Products." It addresses the general provisions and general requirements for Medication Guides.

Guidances

Clinical/Medical

• Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report.   (Issued 8/27/1997, Posted 8/27/1997).

Electronic Submissions (Draft)

• Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports or [PDF] (Issued 5/2001, Posted 5/3/2001)

International Conference on Harmonisation, Efficacy

• E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
• E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case Safety Reports. (Issued 1/15/1998, Posted 1/15/1998).
• E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs. ( Issued 5/19/1997, Posted 3/19/1998).

Procedural (Draft)

• Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines. (Issued 3/2001, Posted 3/9/2001).

Manual of Policies and Procedures (MaPPs)

• 6004.1 Granting Waivers Under 21 CFR 314.90 for Postmarketing Safety Reporting Requirements Under 21 CFR 314.80. (11/16/1999, Posted 11/17/1999).
• 6010.1 NDAs: Preapproval Safety Conferences. (Issued 11/15/1999, Posted 11/17/1999).