federal_register: 2013-14168
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013-14168 | Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in Combination; Availability | Notice | The FDA is announcing the availability of a guidance for industry entitled "Codevelopment of Two or More New Investigational Drugs for Use in Combination." This guidance is intended to assist sponsors in the codevelopment of two or more investigational drugs that have not been previously developed for any indication (i.e., "new investigational drugs") to be used in combination to treat a disease or condition. The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that may arise during codevelopment of two or more new investigational drugs. It is not intended to apply to development of combinations of already approved drugs or to development of a single new investigational drug to be used in combination with an already approved drug or drugs. The guidance is not intended to apply to biological products regulated by the Center for Biologics Evaluation and Research or medical devices. | 2013-06-14 | 2013 | 6 | https://www.federalregister.gov/documents/2013/06/14/2013-14168/guidance-for-industry-on-codevelopment-of-two-or-more-new-investigational-drugs-for-use-in | https://www.govinfo.gov/content/pkg/FR-2013-06-14/pdf/2013-14168.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The FDA is announcing the availability of a guidance for industry entitled "Codevelopment of Two or More New Investigational Drugs for Use in Combination." This guidance is intended to assist sponsors in the codevelopment of two or more investigational... |