§ 314.98 Postmarketing reports

(a) Each applicant having an approved abbreviated new drug application under § 314.94 that is effective must comply with the requirements of § 314.80 regarding the reporting and recordkeeping of adverse drug experiences.

(b) Each applicant must make the reports required under § 314.81 and section 505(k) of the Federal Food, Drug, and Cosmetic Act for each of its approved abbreviated applications.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

Warning letters citing § 314.98

2 FDA warning letters since 2017 cite this section :

• Morton Grove Pharmaceuticals, Inc. 17 Feb 2017
• Hospira Inc 14 Feb 2017

FDA guidance that cites § 314.98

• Certain Postapproval Requirements and Resources for ANDAs 4 Jun 2026
• Pyrogen and Endotoxins Testing: Questions and Answers: Guidance for Industry 18 Mar 2026
• Risk Management Plans to Mitigate the Potential for Drug Shortages draft 19 May 2022
• Providing Submissions in Electronic Format — Postmarketing Safety Reports 27 Apr 2022
• Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry 22 Jul 2021
• Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic 11 May 2020
• REMS Assessment: Planning and Reporting draft 1 Feb 2019
• Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry draft 11 Jul 2016
• CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports 5 Mar 2014
• Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act 30 Jul 2013
• Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application 17 Jul 2009
• Evaluating the Risks of Drug Exposure in Human Pregnancies 27 Apr 2005
• Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for Industry draft 12 Mar 2001

Amendment history

Federal Register documents that created or amended this section.

• 79 FR 33089 10 Jun 2014