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October 19, 2022
An unlikely beacon of hope from the otherwise disastrous Covid pandemic, may come in the form of renewed attention towards approaches to vaccine development. The Importance of Vaccines The...
October 12, 2022
For those who have been awaiting Congressional reauthorization of PDUFA, the wait is over. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. We...
September 27, 2022
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...
September 20, 2022
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...
September 14, 2022
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...
August 26, 2022
Today, FDA announced the availability of the following draft guidances for industry, which were prepared under the support of the International Council for Harmonisation of Technical Requirements for...
August 25, 2022
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...
August 25, 2022
FDA - Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies. August 2022 This final guidance is intended to help applicants (or “you”) design and...
August 25, 2022
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...