USA – FDA issues final guidance on obtaining informed consent in drug and device...
The US Food and Drug Administration (FDA) on Tuesday announced it has finalized guidance to help institutional review boards (IRBs), clinical investigators, and sponsors...
USA – FDA drafts guidance on classification category for biosimilar supplements
The US Food and Drug Administration (FDA) just published draft guidance to assist sponsors determine the appropriate supplement category for biosimilar applications and its...
Europe – Revocation of authorisation for sickle cell disease medicine Adakveo
On 26 May 2023, EMA’s human medicines committee (CHMP) recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises)...
USA – QTc: FDA proposes labeling for heart drugs with heart rhythm risk
The US Food and Drug Administration (FDA) on Monday issued draft guidance offering recommendations for sponsors to include labeling information on QTc interval prolongation...
USA – FDA sets acceptable intake limits for nitrosamines in drugs
The US Food and Drug Administration (FDA) on Friday issued a final guidance that outlines a framework for predicting the mutagenic and carcinogenic risk...
USA – FDA finalizes guidance on DSCSA waivers, exceptions and exemptions
The US Food and Drug Administration (FDA) recently published a final guidance on its process for granting – or denying – waiver, exceptions and...
USA – Drugmakers ask FDA to reconsider concomitant treatment in migraine drug guidance
Four drugmakers have asked the US Food and Drug Administration (FDA) to amend some of the requirements in its draft guidance on developing migraine prevention...
Europe – EMA updates Q&A document on publication of clinical trial data
In December 2018 all Clinical Data Publication (CDP) activities were suspended due to the
implementation of the EMA’s business continuity plan (BCP). During the COVID-19...
Canada – Notice: Release of (Step 4) ICH S12 Guideline – Nonclinical Biodistribution Considerations...
This topic was endorsed by the ICH Assembly in June 2019.
The ICH S12 Guideline reached Step 4 of the ICH process on 14 March 2023.
The ICH...
UK – NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy
The company has been seeking approval for use of the therapy in adults with severe or moderately severe haemophilia B without a history of...
