Description
This is one in a series of guidance documents intended to assist sponsors, applicants, and others making regulatory submissions to the Food and Drug Administration (FDA) in electronic format.
Scope & Applicability
Stakeholders
4Entity responsible for submitting applications under section 524B
Entity submitting development data and knowledge; Entity performing the work process for change
A licensed manufacturer submits an adverse event ICSR
applicants are regarded as first applicants and may be eligible for shared 180-day generic drug exclusivity
Regulatory Context
Attributes
3Date an application is deemed to have arrived at FDA
ANDA will not be considered to be substantially complete when submitted
Date transmission to ESG is completed
Identified Hazards
Hazards
2Safety concern requiring reporting within 15 calendar days
Technical deficiency in electronic submission
Related CFR Sections (5)
- 21CFR312.40§ 312.40 General requirements for use of an investigational new drug in a clinical investigation.
(a) An investigational new drug may be used in a clinical investigation if the following conditions are met:Read full regulation →
- 21CFR314.107§ 314.107 Date of approval of a 505(b)(2) application or ANDA.
(a) General. A drug product may be introduced or delivered for introduction into interstate commerce when the 505(b)(2) application or ANDA for the drug product is approved. A 505(b)(2) application or ANDA for a drug product is approved on the date FDA issues an approval letter under § 314.105 for tRead full regulation →
- 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →
- 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.
(a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead 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 →
Related Warning Letters (6)
- 2025-09-30
Clinical Investigator (Sponsor)
Pamela K. Den Besten, DDS, MS
- 2025-06-10
Clinical Investigator (Sponsor)
American Behavioral Research Institute, LLC
- 2025-02-11
Clinical Investigator
ISOThrive, Inc.
- 2022-11-29
Clinical Investigator (Sponsor)
"David M. Lubeck, M.D./Arbor Centers for EyeCare
- 2021-10-12
Bioresearch Monitoring Program/IRB
RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc.
- 2021-09-07
Bioresearch Monitoring Program
Kaleido Biosciences, Inc.
See Also (8)
- Submitting Debarment Certification Statements (Status: Draft)
- Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (Status: Final)
- 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (Status: Final)
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications: Guidance for Industry (Status: Final)
- Prussian Blue Drug Products — Submitting a New Drug Application (Status: Final)
- Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug Application (Status: Final)