federal_register: 99-9146

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
99-9146 Progestational Drug Products for Human Use; Requirements for Labeling Directed to the Patient Proposed Rule The Food and Drug Administration (FDA) is proposing to revoke its regulation requiring patient labeling for progestational drug products. This patient labeling is required to inform patients of an increased risk of birth defects reported to be associated with the use of these drugs during the first 4 months of pregnancy. FDA has concluded that, based on a review of the scientific data, such labeling for all progestogens is not warranted. In addition, the diversity of drugs that can be described as progestational, and the diversity of conditions these drugs may be used to treat, make it inappropriate to consider these drugs a single class for labeling purposes. This action is intended to provide consumers with more appropriate labeling for certain drug products. 1999-04-13 1999 4 https://www.federalregister.gov/documents/1999/04/13/99-9146/progestational-drug-products-for-human-use-requirements-for-labeling-directed-to-the-patient https://www.govinfo.gov/content/pkg/FR-1999-04-13/pdf/99-9146.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to revoke its regulation requiring patient labeling for progestational drug products. This patient labeling is required to inform patients of an increased risk of birth defects reported to be...  

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