tachypnea definition: nounRapid breathing.Origin of tachypneaNew Latin tachy- Greek pnoiÄ breathing ( from pnein to breathe ; see pneu- in Indo-European roots.)Related Forms: 1. tachâ²ypÂ·neâ²ic adjective...
New Concept paper on Annex 16 of the EU-GMP Guide. The European Medicines Agency (EMA) has published a Concept paper on revising Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release.ince that time, the pharmaceutical environment has been changing and new technologies like, for example, PAT and Real Time Release Testing have been developed. And the implementation of ICH Q8, Q9 and Q10 is having a huge impact on pharmaceutical quality management systems.
FDAâs Expansion of IND Regulations Impose Yet Another Major Regulatory Hurdle for Medical Food Companies By Peter Arhangelsky On October 22, 2013 Â· Add Comment On September 10, 2013, FDA published a new guidance document restricting the scope of research permitted for dietary supplements and medical foods without first submitting an Investigational New Drug application (âINDâ).