federal_register: 2023-07185

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2023-07185 Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry; Availability; Extension of Comment Period Notice The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing the availability of a draft guidance for industry that appeared in the Federal Register of February 13, 2023. In that notice, FDA requested comments on the draft guidance for industry entitled "Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development." The Agency is taking this action to allow interested persons additional time to submit comments. 2023-04-06 2023 4 https://www.federalregister.gov/documents/2023/04/06/2023-07185/considerations-for-long-term-clinical-neurodevelopmental-safety-studies-in-neonatal-product https://www.govinfo.gov/content/pkg/FR-2023-04-06/pdf/2023-07185.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing the availability of a draft guidance for industry that appeared in the Federal Register of February 13, 2023. In that notice, FDA requested...  

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