Clinical (IMP) Drug Supply…It’s Complicated
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...
Clinical Research Solutions
What You Need to Know About Developing Vaccines
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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Prescription Drug User Fee Act (PDUFA) VII and Type D Meetings: A New Mechanism for Interacting with FDA
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...
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...
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
USP and FDA Propose Updates to Good Storage and Distribution Practices
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...
Clinical Research Solutions
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 establishment of the Advanced Therapies Regulation in 2008 in the European...
Clinical Research Solutions
EMA’s Emergency Task Force advises on intradermal use of Imvanex / Jynneos against monkeypox
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 only authorised for...
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...
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 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
UK Paediatric Investigational Plans – what do you need to know?? …and how is it all working in practice??
If a marketing authorisation is planned to be submitted in England, Scotland, and Wales (GB), an MHRA-approved paediatric investigational plan (PIP) is required. Up until January 1, 2021, PIPs were...
How to Fast-Track medicine approval in the UK with the MHRA’s Innovative Licensing and Access Pathway (ILAP)
What is ILAP? What benefits does ILAP provide? How do you access it? With the dust of Brexit settling, the question on most people’s lips (well, those of us in the healthcare sector anyway!) was:...
5 Benefits of Receiving EU PRIME Designation for Medicine Developers
What it is, why it matters, how you can apply and how we can help. What is the PRIME Scheme? You might be forgiven if you don’t know what the PRIority MEdicines (PRIME) scheme is; but if you are in...