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Join our webinar this week as we unravel the intricacies of leveraging FDA interactions to drive your projects forward. 📑 💡Key Insights: • Understand the distinct features of INTERACT, pre-IND, and Type D meetings and their unique requirements. • Discover when and how to prepare comprehensively for successful interactions with the FDA. • Acquire knowledge on engaging with the FDA to optimize decision-making processes in early drug development. 🔗 Register now to secure your spot: https://lnkd.in/dR5wMDCy Don't miss out on this opportunity to elevate your understanding of FDA interactions! #TrialWithoutBorders #HiRO #FDA #PreIND #RegulatoryWebinar

The EMA released a reflection paper on single-arm trials (SATs) as pivotal evidence in marketing authorization applications. While randomized controlled trials remain the gold standard, there are considerations for using SATs. In our latest Regulatory Navigator blog, my colleague Sinan Sarac discusses these considerations and the implications for drug developers and shares advice to engage early with regulators, and be prepared for additional scrutiny when considering SATs as pivotal evidence.

I studied this course. It was useful to catch the general concept up and understand current situation of drug research based on the regulation on FDA and EMA .

Willkommen to Berlin! Welcome to Berlin! Today I am speaking at one of the pre-conference workshops about the "importance of a regulatory strategy in global drug development" and "how to navigate within the regulatory landscape in global drug development" at the #RAPSEuroConvergence conference. Please do not hesitate to come and discuss with me, as a member of the #CencoraPharmaLex Development Consulting team. Looking forward to exchanging with you in the coming days! #Regulatory #Strategy #Drugdevelopment #CencoraPharmaLex

Top Blogs of 2024: #1 "Understanding the Process of Drug Development CMC" This year’s most-read blog offers a masterclass in the complexities of CMC and drug development. It’s a must-read for anyone in the industry! Read the #1 blog of 2024 here: https://bit.ly/4gXawD1 Thank you for joining us on this countdown journey! What was your favorite blog this year? Let us know in the comments! #DrugDevelopment #CMC #TopBlogs2024

Relying on existing data, the 505(b)(2) pathway can streamline the drug approval process, bringing modified versions of existing drugs to market faster and at a lower cost. Is it right for you? Find out: https://bit.ly/3z2jSdB #FDAApprovals #DrugDevelopment #ClinicalTrials

In-use stability and compatibility studies are an essential part of drug development and can be complex and expensive. We posted some points to consider on our news page which may help you in setting up an running a successfull study which meets regulatory expectations

Read our latest guide today, How to Use SENDIG v3.1.1 for Improved Standardization of Drug Development: A Comprehensive Guide, which highlights the importance of SENDIG v3.1.1 for a successful drug development process and provides valuable insights on how to use it effectively. Access this guide to learn about the benefits of SENDIG v3.1.1 and how it can help you streamline your drug development process, reduce errors, and improve overall efficiency. https://hubs.la/Q02DczrM0

New FDA guidance on correspondence related to generic drug is available today This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA’s controlled correspondence response and the Agency’s process for responding to those requests.

Detailed Requirements for Abbreviated New Drug Product Approval: Watch video✔️ The difference between NDA and ANDA check: https://lnkd.in/deGPSZYf Bcs based biowaiver check: https://lnkd.in/dstg6CTN https://lnkd.in/dXU3SJpz #PharmaCores #Creating_New_Dimensions