Description
This Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic investigational new drug application (IND) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This Guide supplements the draft guidance for industryProviding Regulatory Submissions in Electronic Format: IND Safety Reports(October 2019), which implements the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to electronic submissions for certain IND safety reports submitted to CDER or CBER.
Scope & Applicability
Stakeholders
2Entity responsible for submitting applications under section 524B
FDA contact for creating electronic submission accounts
Regulatory Context
Attributes
2The IND under which clinical trials were first initiated in the US
critical information on the PDP
Related CFR Sections (4)
- 21CFR312.32§ 312.32 IND safety reporting.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR600.80§ 600.80 Postmarketing reporting of adverse experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR310.305§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
(a) Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiencRead full regulation →
Related Warning Letters (10)
- 2025-11-25
Compounding Pharmacy/Adulterated Drug Products
Wells Pharma of Houston, LLC
- 2025-05-13
Compounding Pharmacy/Adulterated Drug Products
Tailstorm Health Inc. dba Medivant Health
- 2025-03-25
Compounding Pharmacy/Adulterated Drug Products
Annovex Pharma, Inc.
- 2025-03-04
Compounding Pharmacy/Adulterated Drug Products
ProRx, LLC
- 2024-10-22
Compounding Pharmacy/Adulterated Drug Products
Stokes Healthcare Inc. dba Epicur Pharma
- 2023-08-08
Compounding Pharmacy/Adulterated Drug Products
US Specialty Formulations, LLC
- 2022-01-18
Compounding Pharmacy/Adulterated Drug Products
Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop
- 2021-10-26
Compounding Pharmacy/Adulterated Drug Products
Empower Clinic Services, LLC dba Empower Pharmacy
- 2021-08-31
Compounding Pharmacy/Adulterated Drug Products
AnazaoHealth Corporation
- 2021-08-03
Compounding Pharmacy/Adulterated Drug Products
Farmakeio Outsourcing LLC
See Also (8)
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators (Status: Final)
- Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Draft Guidance for Industry (Status: Draft)
- Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry (Status: Final)
- Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments (Status: Final)
- IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-Investigators (Status: Draft)
- COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (Status: Final)
- Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry (Status: Final)
- Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-Investigators (Status: Draft)