federal_register: 2019-25246
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-25246 | Transdermal and Topical Delivery Systems-Product Development and Quality Considerations; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Transdermal and Topical Delivery Systems--Product Development and Quality Considerations." This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS) regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Specifically, the guidance discusses FDA's current thinking on product design and pharmaceutical development, manufacturing process and control, and finished product control. It also addresses special considerations for areas where quality is closely tied to product performance and potential safety issues, such as adhesion failure and the impact of applied heat on drug delivery. | 2019-11-21 | 2019 | 11 | https://www.federalregister.gov/documents/2019/11/21/2019-25246/transdermal-and-topical-delivery-systems-product-development-and-quality-considerations-draft | https://www.govinfo.gov/content/pkg/FR-2019-11-21/pdf/2019-25246.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Transdermal and Topical Delivery Systems--Product Development and Quality Considerations." This guidance provides recommendations... |