UK needs to sharpen its act on home-brew guidance
This article was originally published in Clinica
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has acknowledged that there are still some shortcomings in its latest guidance to manufacturers on the modification of IVDs purchased from a third party, including when these are so altered that they may be considered as an entirely new product - as "home-brew" manufacture. It is planning to provide additional guidance to IVD users.
You may also be interested in...
While Teva has helped to mitigate a Canadian shortage of salbutamol inhalers, Accord has struck a deal with the UK government to supply hydroxychloroquine. Sandoz is bolstering its inventory to meet demand and Apotex is donating critical medicines, while MedPharm’s new testing model will screen drugs for therapeutic eﬀectiveness and Beximco is focusing on manufacturing hydroxychloroquine, favipiravir and ivermectin.
Virtual trials could be the answer to limitations placed on innovation by the coronavirus pandemic and help companies formulate new health claims relevant to a new generation of consumers, argued IQVIA Consumer Health during a recent webinar.
Discovered at record-breaking speed by AbCellera, Lilly says the antibody candidate could progress into Phase II trials by June.