FDA Guides On Bioequivalence Studies And COVID-19
Offers Advice On Protecting Participants In Studies For ANDAs
Guidance on protecting participants in bioequivalence studies during the COVID-19 pandemic has been published by the FDA.
You may also be interested in...
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.
Advanz Pharma has immediately hit back at a decision announced by the UK’s competition regulator to impose fines of more than £100m over the firm’s historical pricing of liothyronine tablets.
Off-patent industry players from around the globe now have an extra week to submit their achievements to the Global Generics & Biosimilars Awards 2021 being held on 10 November, after the entry deadline was extended by a week to 6 August. Pharmacloud has also joined the event, sponsoring the Leader of the Year category.