federal_register: 2017-08199

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 regulation_id_numbers
2017-08199 Product-Specific Guidance for Naloxone Hydrochloride; New Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entitled "Draft Guidance on Naloxone Hydrochloride." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for naloxone hydrochloride nasal spray. 2017-04-24 2017 4 https://www.federalregister.gov/documents/2017/04/24/2017-08199/product-specific-guidance-for-naloxone-hydrochloride-new-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2017-04-24/pdf/2017-08199.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entitled "Draft Guidance on Naloxone Hydrochloride." The new draft guidance,...  

Links from other tables