This guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for prescription drugs. The disclosure of the product name in promotional labeling and advertisements is important for proper identification and to ensure safe and effective use. This guidance also articulates the circumstances under which FDA intends to refrain from taking enforcement action regarding these requirements. We believe that following this guidance will allow for appropriate advertising and promotion without presenting any public health risk to patients.
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- ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA
- Guiding principles on the use of large language models in regulatory science and for medicines regulatory activities
- IMDRF Document Implementation Report
- Acceptable Media for Electronic Product User Manuals
- FDA final guidance on ‘Electronic Submission Template for Medical Device De Novo Requests’
- Cyber security in the health and medicine sector: a study on available evidence of patient health consequences resulting from cyber incidents in healthcare settings
- ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms – Scientific guideline
- EUDAMED user guide NRDs (Custom made and Old devices) for the Vigilance module