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Comments to FDA on Draft Guidance “Current Good Manufacturing Practice Requirements for Combination Products”

​April 29, 2015

Division of Dockets Management (HFA–305)
Food and Drug Administration
10903 New Hampshire Ave, Bldg 32, Rm 5129
Silver Spring, MD 20993-0002

Re: Docket No. FDA-2015-D-0198 “Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and FDA Staff”


Dear Dockets Manager:

AABB appreciates the opportunity to comment on “Current Good Manufacturing Practice
Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff.” The draft guidance document provides clarification on FDA’s thinking with respect to regulatory considerations for CGMPs for combination products. Section V “Application of CGMP requirements to specific types of combination products” is an especially useful list of hypothetical scenarios. We are grateful that the Agency has taken the step of publishing a draft guidance and we look forward to a finalized version.

AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.

The Center for Cellular Therapies appreciates the opportunity to comment on the draft guidance. Though we have no comments at this time, we look forward to the publication of a finalized guidance document.

Sincerely,
 
Naynesh Kamani, MD
Vice President, Center for Cellular Therapies & Research