Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for Industry

Description

This guidance provides information for firms about how FDA evaluates firms’ medical product communications that fall within the scope of FDA’s regulatory authority (product communications) and that present information not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. For the purposes of this guidance and as further explained in section III, information that is consistent with the FDA-required labeling is limited to information about the approved or cleared uses of a product. The term FDA-required labeling as used in this guidance includes the labeling reviewed and approved by FDA as part of the medical product marketing application review process. For products not subject to premarket approval, but instead subject to premarket notification (510(k)) requirements or exempt from premarket review, the term FDA-required labeling includes the labeling that provides adequate directions for use and other information required to appear on the label or in labeling.

Scope & Applicability

Regulatory Context

• 21CFR814.39§ 814.39 PMA supplements.

  (a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →

• 21CFR601.12§ 601.12 Changes to an approved application.

  (a) General.Read full regulation →

• 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.

  (a) Changes to an approved NDA.Read full regulation →

• 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.

  (a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →

• 21CFR1.21§ 1.21 Failure to reveal material facts.

  (a) Labeling of a food, drug, device, cosmetic, or tobacco product shall be deemed to be misleading if it fails to reveal facts that are:Read full regulation →

• 21CFR201.100§ 201.100 Prescription drugs for human use.

  A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met:Read full regulation →

• 21CFR202.1§ 202.1 Prescription-drug advertisements.

  Prescription drug as used in this section means any drug defined in section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or § 201.105 of this chapter , applicable to drugs intended for use by humans and to veterinary drugs, respectively.Read full regulation →

• 21CFR807.81§ 807.81 When a premarket notification submission is required.

  (a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →

• 21CFR862.9§ 862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

  The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the casRead full regulation →

• Advertising & Promotional Labeling/Drugs/Biological Products

  CSL Behring

  2025-09-16

• False & Misleading Claims/Misbranded

  Aytu Biopharma

  2025-09-16

• 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

  Alora Pharmaceuticals

  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

  Aurora Pharmaceutical

  2025-03-11

• False & Misleading Claims/Misbranded

  Elanco Animal Health

  2025-03-11

• False & Misleading Claims/Misbranded

  Boehringer Ingelheim Animal Health USA

  2024-03-12

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