eCFR Reference Browser

---

title: "21 CFR §314.98"

source: "https://www.ecfr.gov/current/title-21/section-314.98"

title_number: "21"

volume_number: "5"

chapter_number: "Unknown"

subchapter_code: "D"

subchapter_subject: "DRUGS FOR HUMAN USE"

part_code: "314"

part_subject: "APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG"

subpart_code: "C"

subpart_subject: "Abbreviated Applications"

section_number: "314.98"

section_subject: "Postmarketing reports."

cfr_reference: "21 CFR 314.98"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 300 to 499"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§314.98 - Postmarketing reports.