# Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/harmonizing-compendial-standards-with-drug-application-approval-using-the-usp-pending-monograph-process-guidance-for-industry/2bca3b51-14c5-4542-ac74-37c261ce6f8d

> FDA guidance document: Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry. Issue date: July 10, 2019. Get complete insights and analysis.

---

## Details

- Title: Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process 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: 2019-07-10
- Comment Close Date: 2019-09-10
- Last Changed: 2020-01-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-1768 ">FDA-2019-D-1768 </a>

## Related Documents

- [Establishing Impurity Specifications for Antibiotics](https://www.globalkeysolutions.net/guidances/guidance-document/establishing-impurity-specifications-for-antibiotics/5bb8badb-7c32-4b76-bfc9-bbb8ab55fb84)
- [Certification Process for Designated Medical Gases: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/certification-process-for-designated-medical-gases-draft-guidance-for-industry/7af49ba2-f413-448e-a92a-863f161df336)
- [How To Obtain a Covered Product Authorization](https://www.globalkeysolutions.net/guidances/guidance-document/how-to-obtain-a-covered-product-authorization/881f0322-95f9-4bfd-b6c3-35f5df950808)