Clinical Research Solutions
What You Need to Know About CBER Pre-IND Meetings
The FDA provides several opportunities to hold meetings with Sponsors to gain clarification and agreement on the development of medicinal products. At the preliminary stages of development, one such...
Clinical Research Solutions
CAR-T Cells: Challenges, Lessons Learned, and Guidance for the Clinical Development
It comes as no surprise to any pharmaceutical or biotech company that planning the clinical development of CAR-T cells is an extremely challenging endeavor: high efficacy is expected in each targeted...
Clinical Research Solutions
How to Comply with the Nitrosamine Regulations for Your New Drug Product Marketing Applications
Introduction: Are you in the development phase for your medicinal product? Have you assessed your manufacturing processes with respect to the requirements for investigating the potential presence of...
Clinical Research Solutions
FDA Designates Empirically Based Bayesian Emax Models for Dose Finding as ‘Fit-For-Purpose’
FDA Designates Empirically Based Bayesian Emax Models for Dose Finding as ‘Fit-For-Purpose’: On August 5, 2022, the U.S. Food and Drug Administration (FDA) designated ‘Empirically Based Bayesian Emax...
Clinical Research Solutions
FDA Issues FY2021 Report on the State of Pharmaceutical Quality
FDA Issues FY2021 Report on the State of Pharmaceutical Quality: The Office of Pharmaceutical Quality (OPQ) within FDA’s Center for Drug Evaluation and Research has published the fiscal year 2021...
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
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study Many advanced therapy medicinal products (ATMPs) in development in the EU are for rare diseases and conditions. Since the...
Clinical Research Solutions
EMA’s Emergency Task Force advises on intradermal use of Imvanex / Jynneos against monkeypox
August 19, 2022 EMA’s Emergency Task Force (ETF) has reviewed data on the monkeypox vaccine Imvanex 1 used as an intradermal injection (given just below the top layer of the skin). The vaccine is...
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
EMA COVID-19 guidance: research and development
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...