federal_register: E8-29688

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E8-29688 Guidance for Industry on Orally Disintegrating Tablets; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Orally Disintegrating Tablets." The guidance provides pharmaceutical manufacturers of new and generic products with an agency perspective on the definition of an orally disintegrating tablet (ODT) and also provides recommendations to applicants who would like to designate proposed products as ODTs. 2008-12-16 2008 12 https://www.federalregister.gov/documents/2008/12/16/E8-29688/guidance-for-industry-on-orally-disintegrating-tablets-availability https://www.govinfo.gov/content/pkg/FR-2008-12-16/pdf/E8-29688.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Orally Disintegrating Tablets." The guidance provides pharmaceutical manufacturers of new and generic products with an agency perspective on the...

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