Wednesday, March 22, 2023

Very Brief Blog: FDA Issues Draft Guidance for PGx on Drug Labeling

As posted by RAPS "Regulatory Affairs," Mary Ellen Schneider notes that FDA has released for comment a new draft guidance on the use of pharmacogenomics in drug labeling.   (The emphasis is on uses in drug labeling, not the genetic testing itself)

Find the RAPS article here.  Find the 13 page draft document at FDA, here.

It explains how FDA expects applicants to present and use PGx findings and data in regulatory submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs).  Topics include format and level of detail, and this new guidance (when finaled in a year or two) will replace the prior guidance from 2005.  The draft guidance applies to IND submissions and requires detailed reports to be submitted as part of the IND under the Previous Human Experience section, in meeting packages, and in clinical study protocols or reports. 

NDA and BLA sponsors must generally submit the same types of pharmacogenomic data and studies as IND sponsors, though the level of detail varies. 

Comments on the draft guidance can be submitted until 20 June 2023.