Quality Systems

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.

AstraZeneca mAb Approved by FDA for Endometrial Cancer Patients

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

CDER Announces Emerging Drug Safety Technology Meeting Program

Cheryl Barton is director of PharmaVision, 

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

Using RWD in Non-Interventional Studies

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Podcasts

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

The IDAP pilot scheme is designed to accelerate access to innovative medical devices and is a pioneering legislative proposal in the UK medical device space.

Improving Patient Access Through the UK IDAP Scheme

C3TI will promote CDER’s clinical trial innovation activities both internally and externally.

FDA Establishes Center for Clinical Trial Innovation

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

FDA Releases Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

Videos

In this latest installment of the Europa Perspectives series, Alexander Natz, Secretary General at EUCOPE, delves into the European Commission’s new measures aimed at making lifecycle management more efficient across the European Union.

Europa Perspectives on Lifecycle Management

The annual report details OPQ’s quality assurance work for 2023 including its support for the creation of guidance documents.

Regulatory Authority Actions