Clinical Research Solutions
FDA Publishes Responses to Good Clinical Practice Inquiries
FDA Publishes Responses to Good Clinical Practice Inquiries: FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and FDA’s regulations....
Clinical Research Solutions
FDA Pathways to Medical Device Approval
Commercializing your medical device in the US market often requires submitting a marketing application to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA...
Clinical Research Solutions
FDA Solicits Feedback on ANDA Submissions – Amendments to ANDAs Under GDUFA Guidance, Appendix A
Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for...
Clinical Research Solutions
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 to be met in the EU, USA, UK and other regions. These precise...
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
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...
Clinical Research Solutions
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...
Clinical Research Solutions
7 Critical Factors for Successful Selection of CDMO for Cell and Gene Therapy Manufacturing
Developing, optimising, and manufacturing Advanced Therapy Medicinal Products (ATMP's), such as Cell and Gene Therapy (CAGT) products is extremely complex. The choice of a reliable Contract...