Month September 2021

CMDh updates – September 2021

Report from the CMDh meeting held on 14-16 September 2021 The report from the above meeting can be viewed here. It includes the following information: Reminder to MAHs for products containing chlorobutanol as an excipient at a level above the…

EMA and FDA launch pilot program for parallel scientific advice (PSA) for hybrid products and complex generic products

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of marketing authorisation applications (MAAs) for: hybrid products (EMA) and abbreviated new drug applications…