Updated guidance on the development of zinc sulfate product dossiers for submission to PQT/MED

Updated guidance on the development of zinc sulfate product dossiers for submission to PQT/MED has been posted to the PQT/MED website. The newly posted document brings together advice on zinc sulfate products that had been posted in separate documents previously but also contains new information related to the possibility of a waiver from the requirement to conduct a clinical Acceptability Study with a newly developed zinc sulfate product. Such a waiver could eliminate the need to conduct clinical studies with a newly developed zinc sulfate product prior to application to PQT/MED for prequalification of the product.