federal_register: 2012-16244

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
2012-16244 Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use-Labeling for Products That Contain Acetaminophen; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use--Labeling for Products That Contain Acetaminophen." The draft guidance is intended to inform manufacturers of certain over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products that contain acetaminophen of the circumstances in which FDA intends to exercise enforcement discretion with regard to the liver warning required in the labeling. 2012-07-05 2012 7 https://www.federalregister.gov/documents/2012/07/05/2012-16244/draft-guidance-for-industry-on-organ-specific-warnings-internal-analgesic-antipyretic-and https://www.govinfo.gov/content/pkg/FR-2012-07-05/pdf/2012-16244.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use--Labeling for...  

Links from other tables