federal_register: 04-9652

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

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
04-9652 Exocrine Pancreatic Insufficiency Drug Products Notice The Food and Drug Administration (FDA) is announcing that all exocrine pancreatic insufficiency drug products are new drugs and is announcing the conditions for continued marketing of these drug products. Manufacturers who wish to continue to market exocrine pancreatic insufficiency drug products must submit new drug applications (NDAs); manufacturers who contend that a particular drug product is not subject to the new drug requirements of the Federal Food, Drug, and Cosmetic Act (the act) should submit a citizen petition. FDA has determined that prescription exocrine pancreatic insufficiency drug products are medically necessary and, accordingly, is allowing manufacturers 4 years to obtain approved applications. 2004-04-28 2004 4 https://www.federalregister.gov/documents/2004/04/28/04-9652/exocrine-pancreatic-insufficiency-drug-products https://www.govinfo.gov/content/pkg/FR-2004-04-28/pdf/04-9652.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing that all exocrine pancreatic insufficiency drug products are new drugs and is announcing the conditions for continued marketing of these drug products. Manufacturers who wish to continue to market...

Links from other tables