Are you really moving towards a GLocal Regulatory approach?
Are you really moving towards a GLocal Regulatory approach? by: Concetta Aulicino – Regulatory Affairs Executive Consultant – PQE Group According to […]
Tag: FDA
Synthetic Nicotine: Drug or Tobacco Product? Bill H.R. 6286 approval closes the loophole
Synthetic Nicotine: Drug or Tobacco Product? Bill H.R. 6286 approval closes the loophole by: Gurhan Coban – External Opinion Leader While having […]
Covid-19 & Pharmaceutical manufacturing: the challenges for production quality, safety and continuity
Covid-19 & Pharmaceutical manufacturing: the challenges for production quality, safety and continuity by Alessio Rosati Sterility Assurance Executive Consultant – PQE Group
Nitrosamines RA evaluation deadline extended due to coronavirus spreading
European Medicines Regulatory Network agreed to proceed with the extension of the Step 1 (risk evaluation) deadline to October 1st, 2020, due to Covid-19 spreading.
Why MD Cybersecurity is so important
Why MD Cybersecurity is so important by Danilo Maruccia, Executive Consultant & Business Partner – PQE Group Is Cybersecurity important for Medical […]
FDA temporarily raising tolerance on impurities due to market shortage
FDA has issued setting temporary rules on a probable cancer-causing impurity formerly regulated. To avoid market shortage of Losartan, drugmakers will be […]
Olive oil is a medicine according to FDA
Yes it is! Recently the U.S. Food and Drug Administration (FDA) has determined that there is credible evidence to support a qualified […]