PDP
PMA
August 9, 2022
From Idea to Market: The Five Stages of Product Development
From Idea to Market: The Five Stages of Product Development. The exact product development process for medical devices differs from region to region, with different regulatory expectations that need...
Meet the Expert
Renata Pankiewicz
August 8, 2022
Meet the Expert: Renata Pankiewicz
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
FDA
MHRA
August 8, 2022
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...
FDA
North America
August 5, 2022
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...
FDA
North America
August 4, 2022
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....
EMA
Europe
August 3, 2022
EMA: List of centrally authorised products requiring a notification of a change for update of annexes
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...
ANDA
FDA
August 2, 2022
FDA publishes product-specific guidances to facilitate generic drug development
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...
Meet the Expert
Clinical Research Solutions
August 2, 2022
Meet the Expert: Robert Rachford
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
FDA
North America
August 2, 2022
Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry
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...