Clinical Research Solutions
The European Medicines Agency (EMA) provides support to medicine developers researching and developing potential COVID-19 medicines. Dedicated guidance, rapid procedures and contact points are...
Clinical Research Solutions
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
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
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
August 2022 EMA Regulatory and Procedural Guideline Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing...
Clinical Research Solutions
Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug...
Clinical Research Solutions
Guidance Document August 2022 This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt...
Clinical Research Solutions
Guidance Document August 2022 The purpose of this guidance is to advise dietary supplement manufacturers, distributors, and other stakeholders of our intent to exercise enforcement discretion with...
Clinical Research Solutions
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
News July 28, 2022 The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–25. The new...