The FDA issues guidelines for biologics for 2021

The FDA's Center for Biological Product Review and Research (CBER) has released a list of guidelines it plans to add and revise in 2021.
The biologics guidelines are streamlined compared to the drug guidelines development plan released by the FDA last month, with a list of only 14 guidelines, down from 31 in the 2020 guidelines program and 20 in the 2019 guidelines program.
only a few of the 14 guidelines are new, and most retain guidelines that were not released as scheduled in the previous year.
CBER completed and published more than 20 guidelines in its guidance program in 2020, five of which are related to the New Crown (COVID-19) outbreak, including the COVID-19 Vaccine Development, Licensing, and Emergency Use Authorization (EUA) guidelines.
, as was the case last year, CBER said it was "not bound by the guide's list of topics and does not require the publication of each guide in this list" and did not rule out publishing guidelines other than the topics that appeared in the list.
first appeared on this year's guide list are in the tissue and advanced therapy categories, as well as blood and blood components.
CBER said it plans to complete guidance this year on interpreting gene therapy drug similarity in accordance with orphan drug regulations and update its small business compliance guidelines for human cells, tissues and cell-based and tissue-based products (HCT/Ps).
CBER also plans to release draft new guidelines for studying multiple versions of a cell or gene therapy product in clinical trials.
in the blood and blood component categories, CBER plans to update its guidelines on reducing the risk of Zika virus transmission.
CBER's list of guidelines to be released in 2021 is as follows: Category - Blood and blood components are manufactured in blood bodies using equipment that reduces pathogens: Draft guidelines for blood pressure and pulse eligibility requirements for donors in the Q and A Guide (Plan 2020) Draft Guidelines for Alternative Procedures for Refrigerated Plateplates for Blood Transfusions (Plan 2020) Research COVID-19 Rehabilitation through Automatic Collection of Plateplates1 (Plan 2020) Period Plasma Guidelines (published in January 2021) Revised recommendations to reduce the risk of transmission through the blood and blood components of The Zika virus (new in 2021) category - organizations and advanced therapies explain the similarity of gene therapy products in accordance with orphan drug regulations (202) 1 new year) Human gene therapy for neurodegenerative diseases (released in January 2021) Includes draft guidelines for the development of human gene therapy products for genome editing (Plan 2020) embedded antigens (CAR)T Draft Guidelines for Research and Development Considerations for Cell Therapy (Plan 2020) Multiple versions of the Draft Guidelines for Studying a Cell or Gene Therapy Product in Clinical Trials (New in 2021) Human Cell, Tissue, and Cell- and Tissue-Based Products (HCT/Ps) Regulations - Small Business Compliance Guidelines (New in 2021) COVID-19 Public Health Emergencies Approved and researched production considerations for cell and gene therapy products during the event (released in January 2021) category - Other chemical, production, and control changes to approved applications: Certain Biological Products (Plan 2020) 1 CBER plans to issue Level 2 guidelines to revise existing recommendations to address statistical sampling programs for process validation.
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