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USFDA's recent Guidance on Biologics: Ophthalmic Products & Development of (CAR) T Cell Products

1. Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR

This guidance is intended to provide information to applicants and manufacturers regarding compliance with the requirements in part 4 (21 CFR part 4) for ophthalmic drugs packaged with eyecups, eye droppers, or other dispensers.

FDA is issuing this guidance for immediate implementation and applies to products with pending applications, approved products, and products marketed pursuant to section 505G of the FD&C Act (21 U.S.C. 355h) without an approved application under section 505 of the FD&C Act (21 U.S.C. 355) (commonly referred to as over-the-counter (OTC) monograph drugs).

2. Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products

Chimeric antigen receptor (CAR) T cell products are human gene therapy products in which the T cell specificity is genetically modified to enable recognition of the desired target antigen for therapeutic purposes.

This draft guidance is intended to assist sponsors, including industry and academic sponsors, developing CAR T cell products and providing CAR T cell-specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design. Also provides recommendations for analytical comparability studies for CAR T cell products

3. An Acceptable Circular of Information for the Use of Human Blood and Blood Components

This final guidance supersedes the guidance of the same title updated December 2017, and provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion.

Also, this guide will assist you in complying with labeling requirements under 21 CFR 606.122. The requirements under 21 CFR 606.122 specify that a circular of information must be available for distribution with blood and blood components intended for transfusion.


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