federal_register: 2012-30651
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012-30651 | Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of two guidances for industry and investigators entitled "Safety Reporting Requirements for INDs and BA/BE Studies" and "Safety Reporting Requirements for INDs and BA/BE Studies--Small Entity Compliance Guide." These guidances are intended to help sponsors and investigators comply with the requirements in the final rule entitled "Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans," published in the Federal Register on September 29, 2010 (75 FR 59935). FDA has prepared the Small Entity Compliance Guide in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses understand and comply with the regulations issued by FDA concerning safety reporting requirements for investigational new drug applications (IND) and bioavailability (BA) and bioequivalence (BE) studies. | 2012-12-20 | 2012 | 12 | https://www.federalregister.gov/documents/2012/12/20/2012-30651/guidances-for-industry-and-investigators-on-safety-reporting-requirements-for-investigational-new | https://www.govinfo.gov/content/pkg/FR-2012-12-20/pdf/2012-30651.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of two guidances for industry and investigators entitled "Safety Reporting Requirements for INDs and BA/BE Studies" and "Safety Reporting Requirements for INDs and BA/BE... |