federal_register: 2016-20778

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

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
2016-20778 Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on generic risperidone injection, entitled "Bioequivalence Recommendations for Risperidone." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for risperidone injection. 2016-08-30 2016 8 https://www.federalregister.gov/documents/2016/08/30/2016-20778/bioequivalence-recommendations-for-risperidone-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2016-08-30/pdf/2016-20778.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on generic risperidone injection, entitled "Bioequivalence Recommendations for Risperidone." The recommendations provide specific guidance on...

Links from other tables