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federal_register: 96-33098

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present.

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
96-33098 Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Revision of ``Pediatric Use'' Subsection in the Labeling; Extension of Compliance Date Rule The Food and Drug Administration (FDA) is extending the compliance date of a final rule, that published in the Federal Register of December 13, 1994. The document revised the ``Pediatric use'' subsection of the professional labeling requirements for prescription drugs. This final rule extends to April 7, 1997, the date for submission of supplemental applications to comply with the new regulation for those manufacturers who notify FDA in writing by January 29, 1997 of their intent to submit a supplement. The agency is taking this action in response to a request for an extension of the compliance date. 1996-12-30 1996 12 https://www.federalregister.gov/documents/1996/12/30/96-33098/specific-requirements-on-content-and-format-of-labeling-for-human-prescription-drugs-revision-of https://www.govinfo.gov/content/pkg/FR-1996-12-30/pdf/96-33098.pdf Health and Human Services Department 221 The Food and Drug Administration (FDA) is extending the compliance date of a final rule, that published in the Federal Register of December 13, 1994. The document revised the ``Pediatric use'' subsection of the professional labeling requirements for...

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