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Consultations from ICH, European Commission, and FDA

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ISCT Preparing to Submit Comments on Consultations from ICH, European Commission, and FDA

The ISCT Global Regulatory Committees and Lab Practices Committees will be responding to the following consultations. ISCT Members are encouraged to submit comments through to Audrey Le (audrey@isctglobal.org) for consideration in the final submission.

ICH Consultations:

ICH Q2(R2) Validation of Analytical Procedures [Consultation closes July 31]
ICH Q14 Analytical Procedure Development [Consultation closes July 31]

ICH guideline E11A on pediatric extrapolation [Consultation closes Aug 6]

ISCT has completed its solicitation of comments for the above consultations.

European Commission Consultation:

European Commission Adoption Period - Standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC [Consultation Closes Sept 8]

Deadline to submit comments to ISCT - August 15

FDA Consultation:

FDA Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies [Consultation Closes Sept 14]

Deadline to submit comments to ISCT - August 15

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