federal_register: 05-22012

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

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
05-22012 Determination of Regulatory Review Period for Purposes of Patent Extension; ZOMETA; Correction Notice The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 28, 2003 (68 FR 9690). The document announced that FDA had determined the regulatory review period for ZOMETA. A Request for Revision of Regulatory Review Period was filed for the product on May 4, 2005. FDA reviewed its records and found that the effective date of the investigational new drug application (IND) was incorrect due to a clerical error. Therefore, FDA is revising the determination of the regulatory review period to reflect the correct effective date for the IND. 2005-11-04 2005 11 https://www.federalregister.gov/documents/2005/11/04/05-22012/determination-of-regulatory-review-period-for-purposes-of-patent-extension-zometa-correction https://www.govinfo.gov/content/pkg/FR-2005-11-04/pdf/05-22012.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 28, 2003 (68 FR 9690). The document announced that FDA had determined the regulatory review period for ZOMETA. A Request for Revision of...

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