federal_register: 2015-32316
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015-32316 | Draft Guidance for Industry on Advancement of Emerging Technology Applications To Modernize the Pharmaceutical Manufacturing Base; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base." This guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging manufacturing technology. The program is open to companies that intend the technology to be submitted as part of an investigational new drug application (IND), or an original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA) reviewed by the Center for Drug Evaluation and Research (CDER), where that technology meets certain criteria described in the guidance. | 2015-12-23 | 2015 | 12 | https://www.federalregister.gov/documents/2015/12/23/2015-32316/draft-guidance-for-industry-on-advancement-of-emerging-technology-applications-to-modernize-the | https://www.govinfo.gov/content/pkg/FR-2015-12-23/pdf/2015-32316.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base." This guidance provides... |