# Product Title and Initial US Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/product-title-and-initial-us-approval-in-the-highlights-of-prescribing-information-for-human-prescription-drug-and-biological-products-content-and-format-guidance-for-industry/e7792ae4-c049-4de1-bf07-f0bf1ff29121

> FDA guidance document: Product Title and Initial US Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry. Issue date: January 19, 2018. Get complete insights and analysis.

---

## Details

- Title: Product Title and Initial US Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2018-01-19
- Comment Close Date: 2018-03-19
- Last Changed: 2020-04-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-6969">FDA-2017-D-6969</a>

## Related Documents

- [Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/immunogenicity-information-in-human-prescription-therapeutic-protein-and-select-drug-product-labeling-content-and-format-draft-guidance-for-industry/7ecfa0a7-217f-451f-a5d5-0ffe4d7afd5d)
- [Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/indications-and-usage-section-of-labeling-for-human-prescription-drug-and-biological-products-content-and-format-guidance-for-industry/7d286113-df13-47f4-bc30-1a4d819e56c9)
- [Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format](https://www.globalkeysolutions.net/guidances/guidance-document/dosage-and-administration-section-of-labeling-for-human-prescription-drug-and-biological-products-content-and-format/e2343785-81a2-4852-aba8-7ffd3a086deb)