GUIDANCE DOCUMENT
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin November 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Submit Comments by
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-2512
- Docket Number:
- FDA-2022-D-2512
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guideline concerns the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should be submitted in marketing application and registration packages for those products. Biotechnology products include biotherapeutics and certain biological products derived from cell cultures initiated from characterised cell banks of human or animal origin (e.g., mammalian, avian, insect). In this document, the term “virus” excludes non-conventional transmissible agents like those associated with mammalian prions (e.g., bovine spongiform encephalopathy, scrapie). Applicants are encouraged to discuss bovine spongiform encephalopathy-associated issues with the appropriate regulatory authorities.