International – Vaccine makers call for alternative study designs for COVID vaccines

Regulators need to facilitate new ways of clinically validating COVID-19 vaccines now that effective shots are being given around the world, Thomas Triomphe, executive...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – Guideline for Elemental Impurities Q3D(R1)

Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present...
Médicaments : quelle(s) réalité(s) ?

International – Médicaments : quelle(s) réalité(s) ?

Le blog Rédaction Médicale et Scientifique a publié pas moins de 17 billets durant le mois d'août 2019 avec des données réalistes sur les...

International – ICH M12: Pharma industry wants clarity on rifampin dosing, more information on...

The pharmaceutical industry would like the International Council for Harmonization (ICH) to clarify dosing information for rifampin and requests additional information on the use...

International – Le plasma provenant de personnes ayant guéri de la COVID-19 est-il un...

La maladie à coronavirus 2019 (COVID-19) est une maladie respiratoire hautement infectieuse causée par un type de coronavirus nouvellement reconnu. Certaines personnes sont gravement...
The Transformation of Digital Health: What it Means for Regulatory Professionals

The Transformation of Digital Health: What it Means for Regulatory Professionals

Articles throughout November focused on what the changing digital health landscape, including big data, means for regulatory professionals. Leaders in the digital health space...

International – Pfizer/BioNTech to develop a booster dose for their COVID-19 vaccine

The news closely follows an announcement from Moderna, which also said that it would be testing an additional booster dose of its COVID-19 vaccine. The aim of...
PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

International – PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that...

Russia – AstraZeneca confirms Russia vaccine deal days after COVID-19 hacking accusations surface

Last week, Western intelligence officials pegged Russian hackers with an attempt to rip off leading research for a COVID-19 vaccine, linking the would-be thieves...

International – ICH guideline M10 on bioanalytical method validation and study sample analysis –...

In response to questions posted to ICH M10 comment period, a number of Questions and Answers have been devised to provide clarity around some...

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