federal_register: E9-23519
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E9-23519 | Postmarketing Safety Reporting for Combination Products | Proposed Rule | The Food and Drug Administration (FDA) proposes to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, the rule will clarify the postmarketing safety reporting requirements that apply when regulated articles (drugs, devices, and biological products) are combined to create a combination product. The proposed rule is intended to promote and protect the public health by clarifying requirements for postmarketing safety reporting for combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products. | 2009-10-01 | 2009 | 10 | https://www.federalregister.gov/documents/2009/10/01/E9-23519/postmarketing-safety-reporting-for-combination-products | https://www.govinfo.gov/content/pkg/FR-2009-10-01/pdf/E9-23519.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) proposes to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, the rule will clarify the postmarketing safety reporting... |