federal_register: 2021-26734
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021-26734 | Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "CMC Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports." This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA generally considers to have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. Under FDA regulations, such minor changes in the product, production process, quality controls, equipment, facilities, or responsible personnel must be documented by applicants in an annual report. The guidance finalizes the draft guidance of the same title dated August 2017. | 2021-12-10 | 2021 | 12 | https://www.federalregister.gov/documents/2021/12/10/2021-26734/chemistry-manufacturing-and-controls-postapproval-manufacturing-changes-for-specified-biological | https://www.govinfo.gov/content/pkg/FR-2021-12-10/pdf/2021-26734.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "CMC Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports." This guidance... |