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Quality & Compliance
From April 2022, the MHRA has been developing a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM) on behalf of companies that have...
Quality & Compliance
It is quite common that a sponsor company will outsource services to external vendors, whether for additional expertise, remote locations, or simply due to lack of availability of resources within...
Regulatory Sciences
The accelerated approval provisions of FDASIA in section 506(c) of the FD&C Act provide that FDA may grant accelerated approval to: . . . a product for a serious or life-threatening disease or...
Things to consider and how to ease the process IMP Supply Management is a journey where GMP meets GCP and GDP. This journey includes finance, flow of products and documentation. How a company manages...
Regulatory Sciences
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...
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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...
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...
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...
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...
Regulatory Sciences
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 nitrosamine...
Quality & Compliance
Updates have been announced by FDA and for USP <1079>. In this blog we cover these changes. USP USP <1079> has a series of chapters on Good Storage and Distribution Practices. Chapter <1079> applies...
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 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...
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...
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....
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
The key to successful drug development in the US is directional and focused navigation of FDA’s Investigational New Drug (IND) process. The Chemistry, Manufacturing, and Controls (CMC) section is a...