NICE endorsement means more donor livers could be used for transplantation

UK – NICE endorsement means more donor livers could be used for transplantation

A perfusion machine, which can keep a donated liver viable for transplantation for longer, reduces the rate of tissue deterioration that occurs after the...
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

USA – FDA Unveils New Tables for Submitting Bioanalytical Methods

The US Food and Drug Administration (FDA) recently released tables that can be included in submissions for new drug and biologic applications to provide...
EudraVigilance - Inclusion/exclusion criteria for the 'Important medical events' list

Europe – EMA Offers Guidance on Conducting Trials During the COVID-19 Pandemic

The European Medicines Agency (EMA), Good Clinical Practice (GCP) Inspectors Working Group, the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of...
New guidance on biologics affects authorized generics

USA – FDA program to share patient-reported outcomes in cancer drug trials

The U.S. Food and Drug Administration announced a new pilot program Tuesday to share information on symptoms patients report while undergoing clinical cancer drug...
Guidelines For Mobile Health Applications – Examining The Xcertia Guidelines' Initial Release

Europe – Review and update of EMA guidelines to implement best practice with regard...

In February 2014, CHMP and CVMP published a joint concept paper announcing a review and update of EMA guidelines to implement best practice with...
Institutional Review Board (IRB) submissions: Necessary for usability tests?

USA – FDA: No clear proof NSAIDS can worsen COVID-19

The Food and Drug Administration (FDA) has issued a statement regarding the use of nonsteroidal anti-inflammatory drugs (NSAIDS) in patients with coronavirus disease 2019...

USA – FDA finalizes certificates of confidentiality guidance

The US Food and Drug Administration (FDA) finalized its guidance explaining how sponsors can request certificates of confidentiality (CoC) meant to protect the privacy...
Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)

Europe – ICH guideline S11 on nonclinical safety testing in support of development of...

The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety assessments to support the development of...
India Adds Four Medical Device Types to CDSCO List of Regulated Products

India – India’s CDSCO Seeks Feedback From Users of Online Drug, Medical Device Portals

India’s Central Drugs Standard Control Organization (CDSCO) is seeking feedback on its Sugam online portal. The consultation is designed to ascertain how users feel...
PredictSURE IBD gains CE mark, set for UK and EU launch

UK – NICE green light for Cablivi in rare blood-clotting disorder

The new NICE guidance applies to the treatment of an acute episode of aTTP in adults and in young people aged 12 years and...

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