federal_register: 99-23009

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99-23009 Draft Guidance for Industry on BA and BE Studies for Orally Administered Drug ProductsGeneral Considerations; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``BA and BE Studies for Orally Administered Drug Products--General Considerations.'' This draft guidance provides recommendations to sponsors and applicants intending to submit bioavailability (BA) and/or bioequivalence (BE) information in investigational new drug applications (IND's), new drug applications (NDA's), abbreviated new drug applications (ANDA's), and their amendments and supplements, to the Center for Drug Evaluation and Research (CDER). This draft guidance provides general information on how to comply with the BA and BE requirements for orally administered dosage forms in 21 CFR part 320. It is one of a set of planned core guidances designed to reduce and/or eliminate the need for FDA drug-specific BA/BE guidances. 1999-09-03 1999 9 https://www.federalregister.gov/documents/1999/09/03/99-23009/draft-guidance-for-industry-on-ba-and-be-studies-for-orally-administered-drug-productsgeneral https://www.govinfo.gov/content/pkg/FR-1999-09-03/pdf/99-23009.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``BA and BE Studies for Orally Administered Drug Products--General Considerations.'' This draft guidance provides recommendations to...

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