federal_register: 2020-07751
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-07751 | Product-Specific Guidances; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of final guidances for industry entitled "Guidance on Chloroquine Phosphate" and "Guidance on Hydroxychloroquine Sulfate." These guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidance entitled "Guidance on Hydroxychloroquine Sulfate" was developed using the process described in that guidance and finalizes the draft guidance of the same title issued in April 2011. The guidance entitled "Guidance on Chloroquine Phosphate" is being implemented without prior public comment because FDA has determined that prior participation for this guidance is not feasible or appropriate in light of the Coronavirus Disease 2019 (COVID-19) public health emergency but remains subject to comment in accordance with the Agency's good guidance practices. | 2020-04-14 | 2020 | 4 | https://www.federalregister.gov/documents/2020/04/14/2020-07751/product-specific-guidances-guidance-for-industry-availability | https://www.govinfo.gov/content/pkg/FR-2020-04-14/pdf/2020-07751.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 final guidances for industry entitled "Guidance on Chloroquine Phosphate" and "Guidance on Hydroxychloroquine Sulfate." These guidances provide product-specific... |