federal_register: 2010-31426
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010-31426 | Draft Guidance for Industry on Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination." This guidance is intended to assist sponsors in the codevelopment of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition. This guidance provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during codevelopment. The guidance is not intended to apply to development of fixed-dose combinations of already marketed drugs or to development of a single new investigational drug to be used in combination with an approved drug or drugs. The guidance is also not intended to apply to vaccines, gene or cellular therapies, blood products, or medical devices. | 2010-12-15 | 2010 | 12 | https://www.federalregister.gov/documents/2010/12/15/2010-31426/draft-guidance-for-industry-on-codevelopment-of-two-or-more-unmarketed-investigational-drugs-for-use | https://www.govinfo.gov/content/pkg/FR-2010-12-15/pdf/2010-31426.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination." This guidance is intended to assist sponsors in the... |