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...
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...
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...
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...
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...
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...
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 – 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...
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...
