federal_register: 00-14986
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 00-14986 | Draft Guidance for Industry on Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis." Parathyroid hormone (PTH) is being studied for use in the prevention and treatment of osteoporosis. In response to preclinical studies submitted to FDA in which osteosarcomas developed in rats and mice following administration of PTH and related peptides, the agency is developing guidance for the development of PTH as a drug for osteoporosis. This guidance is intended to improve the benefit to risk ratio of treatment with PTH and related peptides. | 2000-06-14 | 2000 | 6 | https://www.federalregister.gov/documents/2000/06/14/00-14986/draft-guidance-for-industry-on-development-of-parathyroid-hormone-for-the-prevention-and-treatment | https://www.govinfo.gov/content/pkg/FR-2000-06-14/pdf/00-14986.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Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis." Parathyroid hormone (PTH) is being studied for use in... |