This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12.
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 product quality.
Under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities, or responsible personnel that have a minimal potential to have an adverse effect on product quality must be documented by applicants in an annual report.
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Also, USFDA released a few more guidance’s this week
The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products, including antibacterial, antifungal, and antiparasitic products, for the paediatric population.
2. Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products (Draft Guidance)
The purpose of this guidance is to help sponsors in the clinical development of products for bowel cleansing in preparation for a colonoscopy.
Specifically, this guidance describes the FDA’s current thinking about the necessary attributes of clinical trials for drugs being developed under Section 21 U.S.C §355 and 21 CFR Parts 312 and 314 for use as bowel cleansing agents before colonoscopy, including trial population, trial designs, efficacy considerations, and safety assessments.
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