federal_register: 2017-16718
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-16718 | Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports." This draft guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to be documented in annual reports. Specifically, the draft guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that the Agency generally considers to have a minimal potential to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. | 2017-08-09 | 2017 | 8 | https://www.federalregister.gov/documents/2017/08/09/2017-16718/chemistry-manufacturing-and-controls-postapproval-manufacturing-changes-for-specified-biological | https://www.govinfo.gov/content/pkg/FR-2017-08-09/pdf/2017-16718.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports." This draft guidance... |