Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry

Description

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Postmarketing Studies and Clinical Trials:  Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act.”  The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to require certain postmarketing studies and clinical trials for prescription drugs at the time of approval or after approval if FDA becomes aware of new safety information.  This draft guidance describes the factors FDA considers when determining whether an applicant has demonstrated good cause for failure to comply with the timetable for completion of studies or clinical trials required under the provisions.  This draft guidance also provides information on relevant procedures, including how an applicant should communicate with FDA regarding compliance with these required studies and trials and describes actions FDA may take for noncompliance with the requirements.

Key Topics

Terms and concepts identified from this document

• 21CFR314.55§ 314.55 Pediatric use information.

  (a) Required assessment. Except as provided in paragraphs (b) , (c) , and (d) of this section, each application for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration shall contain data that are adequate to assess the safety and effectivenessRead full regulation →

• 21CFR601.27§ 601.27 Pediatric studies.

  (a) Required assessment. Except as provided in paragraphs (b) , (c) , and (d) of this section, each application for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration shall contain data that are adequate to assess the safety and effectivenessRead full regulation →

• 21CFR314.510§ 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.

  FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predicRead full regulation →

• 21CFR601.41§ 601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.

  FDA may grant marketing approval for a biological product on the basis of adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, tRead full regulation →

• 21CFR314.610§ 314.610 Approval based on evidence of effectiveness from studies in animals.

  (a) FDA may grant marketing approval for a new drug product for which safety has been established and for which the requirements of § 314.600 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the drug product is reasonably likely to Read full regulation →

• 21CFR601.91§ 601.91 Approval based on evidence of effectiveness from studies in animals.

  (a) FDA may grant marketing approval for a biological product for which safety has been established and for which the requirements of § 601.90 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the biological product is reasonably likRead full regulation →

• 21CFR314.81§ 314.81 Other postmarketing reports.

  (a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →

• 21CFR601.70§ 601.70 Annual progress reports of postmarketing studies.

  (a) General requirements. This section applies to all required postmarketing studies (e.g., accelerated approval clinical benefit studies, pediatric studies) and postmarketing studies that an applicant has committed, in writing, to conduct either at the time of approval of an application or a suppleRead full regulation →

Deficiencies cited in Warning Letters referencing the same regulations

• False & Misleading Claims/Misbranded

  Novo Nordisk Inc.

  2025-09-16

• False & Misleading Claims/Misbranded

  Eli Lilly and Company

  2025-09-16

• False & Misleading Claims/Misbranded

  Eli Lilly and Company

  2025-09-16

• False & Misleading Claims/Misbranded

  Eli Lilly and Company

  2025-09-16

• False & Misleading Claims/Misbranded

  Sprout Pharmaceuticals, Inc.

  2025-06-10

• False & Misleading Claims/Misbranded

  Sarfez Pharmaceuticals, Inc.

  2025-05-20

• False & Misleading Claims/Misbranded

  CooperSurgical, Inc.

  2021-02-23

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