You are here: Industry Insights > guidance

News List

FDA updates Covid-19 variant guidance for vaccines and therapies pharmaceutical-technology
February 25, 2021
US healthcare regulator the Food and Drug Administration (FDA) has updated its guidance to help vaccine and therapeutics companies to address the emergence of new variants of SARS-CoV-2, the virus that causes Covid-19.
EU releases guidance for medicine shortages europeanpharmaceuticalreview
July 09, 2019
The EU has issued two guidance documents intended to advise the pharmaceutical industry and patients during medicinal shortages.
FDA releases guidance on pharmaceutical product labelling europeanpharmaceuticalreview
July 05, 2019
New guidance drafts have been announced by the FDA to improve patients understanding and keep information consistent.
New guidance issued for 3D-printed Medical Device License applicants europeanpharmaceuticalreview
May 15, 2019
Health Canada has published new guidance for manufacturers of higher-risk 3D-printed medical devices.
NICE final guidance published for Cimzia pharmatimes
April 21, 2019
The National Institute for Health and Care Excellence (NICE) has shared its final guidance for the recommended use of UCB’s Cimzia (certolizumab pegol).
UK royal college updates guidance on combined hormonal contraception pharmaceutical-technology
January 22, 2019
The UK Royal College of Obstetricians and Gynaecologists’ Faculty of Sexual and Reproductive Healthcare (FSRH) has updated its guidance on combined hormonal contraception to ......
Data integrity and compliance with drug current good manufacturing practices europeanpharmaceuticalreview
December 14, 2018
The FDA has provided guidance on data integrity and compliance; two areas extremely important for pharmaceutical businesses and manufacturers to adhere to…
Takeda financials show why the Shire deal was needed pharmafile
May 15, 2018
After posting its financials from 2017 and its guidance for the year to come, it’s clear to see why Takeda needed to inject some growth into the company through its mega-merger with Shire.