# Seventh of a series of letters about the Act providing guidance on the "130-day exclusivity" provision of section 505(j)(4)(B)(iv) of the FD&C - FDA Guidance Document

Source: https://www.keypedia.com/guidances/industry-letter/seventh-of-a-series-of-letters-about-the-act-providing-guidance-on-the-130-day-exclusivity-provision-of-section-505j4biv-of-the-fdc/a4371ce8-e046-48b5-bfb0-7b05ef16a136

> FDA guidance document: Seventh of a series of letters about the Act providing guidance on the "130-day exclusivity" provision of section 505(j)(4)(B)(iv) of the FD&C. Issue date: July 29, 1988. Get complete insights and analysis.

---

## Details

- Title: Seventh of a series of letters about the Act providing guidance on the "130-day exclusivity" provision of section 505(j)(4)(B)(iv) of the FD&C
- Communication Type: Industry Letter
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Issue Date: 1988-07-29

## Related Documents

- [Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry](https://www.keypedia.com/guidances/guidance-document/providing-regulatory-submissions-in-electronic-format-submission-of-manufacturing-establishment-information-guidance-for-industry/0221e8af-59ae-437d-88f1-5504fb12c147)
- [Continuation of a series of letters communicating interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program](https://www.keypedia.com/guidances/industry-letter/continuation-of-a-series-of-letters-communicating-interim-and-informal-generic-drug-policy-and-guidance-availability-of-policy-and-procedure-guides-and-further-operational-changes-to-the-generic-drug-review-program/8f5cb94a-7f64-47ac-90d8-9cba28f8e853)
- [Study and Evaluation of Sex Differences in the Clinical Evaluation of Drugs:  Guidance for Industry](https://www.keypedia.com/guidances/guidance-document/study-and-evaluation-of-sex-differences-in-the-clinical-evaluation-of-drugs-guidance-for-industry/3a0ffb0a-7a37-4bc1-87ac-ca6b3fb05058)