October 2023 – Contents
Veterinary medicines: the challenges of new regulation
Transition to the new QRD template for veterinary medicines: challenges and opportunities
Autogenous vaccines under Regulation (EU) 2019/6
Prequalification of veterinary vaccines and medicines
EMA activities related to antiparasitic veterinary medicinal products
Optimal materials selection in medical device development – a proactive biocompatibility approach
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South Africa set to investigate J&J over MDR-TB drug pricing
Johnson & Johnson is set to be investigated by South Africa’s Competition Commission for its prices charged for TB drug bedaquiline.
EMA suggests novel method to assess CKD therapy efficacy
Glomerular filtration rate slope can be used as a surragate end point to assess clinical benefit for treatments in chronic kidney disease in some trial settings.
NICE recommends AI to aid radiotherapy treatment in England
First guidance from National Institute for Health and Care Excellence for use of artificial intelligence as tool for healthcare professionals.
FDA committee finds OTC decongestants
to be ‘ineffective’
An FDA committee has reviewed phenylephrine − the active ingrediant in many over the counter decongestants − and agreed it is ineffective.
EMA future ‘VetMeds’ for healthy animals and humans; seminar
In the lead up to the EMA’s Veterinary Awareness Day, Ivo Classen sits down to discuss the agency’s progress in the field of veterinary medicines.
Covid vaccines ‘not to be offered routinely’ to healthy under-65s
Only over-65s will get vaccination offered this year, the Joint Committee on Vaccination and Immunisation has advised UK government.
UK doubles capacity for certification of medical devices
TÜV SÜD, Intertek, and TÜV Rheinland UK have been designated as UK Approved Bodies to assess and certify general medical devices.
MHRA publishes ‘recognition route’ revised guidance
Semaglutide may help with PCOS and addiction disorders
Burkina Faso gives R21 malaria vaccine approval in children
Global life sciences consultancy created from SSI/NDA merger
Human COVID drug set to treat FCov-23 coronavirus in cats
Devices sold on second-hand market retain sensitive data
Rapid COVID-19 breath test device shows promise
MHRA publishes ‘recognition route’ revised guidance
Semaglutide may help with PCOS and addiction disorders
Burkina Faso gives R21 malaria vaccine approval in children
Global life sciences consultancy created from SSI/NDA merger
Human COVID drug set to treat FCov-23 coronavirus in cats
Devices sold on second-hand market retain sensitive data
September 2023 – Contents
The worldwide web of regulation
Q&A:
Navigating the
pharmaceutical supply chainNavigating the global supply of starting materials for cell-based therapies
Regulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry
Biosimilars CMC development considerations from the sponsor perspective
Warning letters for direct-to-consumer advertising: a five-year retrospective analysis
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RegRapPod − September 2023
Vol.20 #8: In the September 2023 episode of RegRapPod, podcast host Alan Booth hears from Issue Editor Vickie Goff about globalisation and the supply chain.
Created with Supersurvey
Editor's pick
European Parliament gives first stage approval for revised EMA fees
Change Across the Medical Device Landscape
Northern Ireland deal permits GB medicines but not medical devices
UK set to accept CE mark for medical devices until 2028
US Food and Drug Law Institute Annual Conference
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