EMA tools to foster development of new and innovative medicines. The European Medicines Agency (EMA) released a new infosheet that provides regulatory and scientific guidance to foster development of ...
The Office of Generic Drugs started to send out official correspondence saying that an amendment submitted without a verification statement is deficient, because it is not reflecting a new ANDA sectio...
The portal is called IRIS and as of 19 September will be the mandatory submission process for Orphan Drug Designations (ODD) applications. It can be used to manage all important ODD activities includi...
For the marketing authorisation of plasma-derived medicinal products, the plasma master file (PMF) certification is used. The PMF is a compilation of all the required scientific data on the quality, s...
"FDA Open Seminar: All you need to know!" will provide a structured introduction to all important aspects of FDA Regulatory Affairs, but will also cover current hot topics as well as recent changes in...
With more than 20 years of experience in the European regulatory environment, our speakers will present the important steps for setting the strategy for successful European submissions