Clinical Research Solutions
Early engagement with Health Technology Assessment authorities will accelerate product launch and improve chances for reimbursement
Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...
Clinical Research Solutions
FDA Publishes Complex Generics News Resource
Today the FDA is publishing a new web page to share the most recent FDA actions and activities related to complex generics. This new resource is part of FDA’s continued commitment to ensuring...
Clinical Research Solutions
FDA Recognizes August as National Immunization Awareness Month
National Immunization Awareness Month provides us an opportunity to think about how far the development and advancement of immunization science has come, and its impact on public health. The U.S....
Clinical Research Solutions
UK Paediatric Investigational Plans – what do you need to know?? …and how is it all working in practice??
If a marketing authorisation is planned to be submitted in England, Scotland, and Wales (GB), an MHRA-approved paediatric investigational plan (PIP) is required. Up until January 1, 2021, PIPs were...
Clinical Research Solutions
FDA announces the availability of a proposed rule: Revising the National Drug Code Format and Drug Label Barcode Requirements
On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351), that is intended to...
Clinical Research Solutions
EMA Good clinical practice (GCP) inspection procedures
The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
Clinical Research Solutions
FDA Issues Two Draft Guidances Related to the Drug Supply Chain Security Act
FDA Issues Two Draft Guidances Related to the Drug Supply Chain Security Act FDA is announcing the availability of two guidances to help trading partners comply with the Drug Supply Chain Security...
Clinical Research Solutions
Global regulators agree on key principles on adapting vaccines to tackle virus variants
News 01/07/2022 On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop...
Clinical Research Solutions
Maximising on Scientific Advice Procedures in Europe
A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...
Clinical Research Solutions
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
Guidance Document Guidance for Industry and Food and Drug Administration Staff JUNE 2022 This guidance document provides FDA's recommendations on the information, technical performance assessment,...