federal_register: 2019-27354
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-27354 | Bridging for Drug-Device and Biologic-Device Combination Products; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Bridging for Drug-Device and Biologic-Device Combination Products." This draft guidance, when finalized, will represent the Agency's thinking on how to approach bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-device and biologic-device single entity or co-packaged combination products and will help to fulfill the performance goals under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). For the purposes of this guidance, the term bridging refers to the process of establishing the scientific relevance of information developed in an earlier phase of the development program or another development program to support the combination product for which an applicant is seeking approval. Once the applicant has established the relevance of such information to (i.e., bridged to) its product, the applicant may be able to leverage that information to streamline the development program. | 2019-12-19 | 2019 | 12 | https://www.federalregister.gov/documents/2019/12/19/2019-27354/bridging-for-drug-device-and-biologic-device-combination-products-draft-guidance-for-industry | https://www.govinfo.gov/content/pkg/FR-2019-12-19/pdf/2019-27354.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Bridging for Drug-Device and Biologic-Device Combination Products." This draft guidance, when finalized, will represent the... |