federal_register: 2012-27724
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012-27724 | Compliance Guidance for Small Business Entities on Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a compliance guidance for small business entities entitled "Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Small Entity Compliance Guide." This guidance is intended to help small businesses understand and comply with the requirements of the final rule that provides new labeling applicable to all over-the- counter (OTC) bronchodilator drug products marketed without an approved application. The guidance describes the bronchodilator labeling requirements in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Fairness Act. | 2012-11-15 | 2012 | 11 | https://www.federalregister.gov/documents/2012/11/15/2012-27724/compliance-guidance-for-small-business-entities-on-labeling-for-bronchodilators-cold-cough-allergy | https://www.govinfo.gov/content/pkg/FR-2012-11-15/pdf/2012-27724.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a compliance guidance for small business entities entitled "Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for... |