federal_register: 2014-25532
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-25532 | Draft Guidance for Industry on Qualification for the Use of Galactomannan in Serum and Bronchoalveolar Lavage Fluid; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Draft Guidance on Qualification of Biomarker--Galactomannan in Studies of Treatments of Invasive Aspergillosis." This draft guidance provides recommendations on the use of Galactomannan detection in serum and/or bronchoalveolar lavage (BAL) fluid as the sole microbiological criterion to classify patients as having probable invasive Aspergillosis (IA) for enrollment in clinical trials. This draft guidance provides the context of use for which this biomarker drug development tool (DDT) is qualified through the Center for Drug Evaluation and Research (CDER) DDT Qualification Program. In the Federal Register of January 7, 2014, FDA announced the availability of a guidance for industry entitled "Qualification Process for Drug Development Tools," which described the process that would be used to qualify DDTs and to make new DDT qualification recommendations available on FDA's Web site. The qualification recommendations in this draft guidance were developed using the process described in that guidance. | 2014-10-27 | 2014 | 10 | https://www.federalregister.gov/documents/2014/10/27/2014-25532/draft-guidance-for-industry-on-qualification-for-the-use-of-galactomannan-in-serum-and | https://www.govinfo.gov/content/pkg/FR-2014-10-27/pdf/2014-25532.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Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Draft Guidance on Qualification of Biomarker--Galactomannan in Studies of Treatments of Invasive Aspergillosis." This draft guidance... |