FDA’s information source for small pharmaceutical business and industry; CDER SBIA educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
External link for CDER Small Business and Industry Assistance (SBIA)
📣Test yourself before the April 25 Facilitating Generic Drug Product Development through Product-Specific Guidances webinar. Answer the question below and check the results when the poll closes. Don’t forget to register: https://lnkd.in/ev-PWSt8 Enjoy the webinar!
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📣 Today, FDA is announcing a revised draft guidance to answer questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars. Read Draft Guidance Here: https://lnkd.in/exu6ifvY
✅ Did you catch the Overview of the FDA’s Product-specific guidance program at the Generic Drugs Forum? 📣 #DYK that we have a webinar on April 25th dedicated to just product-specific guidances? Become an expert. Register now ➡️ https://lnkd.in/ev-PWSt8
A must attend webinar for anyone in the generic drug industry who wants to learn about the redesigned scope and features of pre-ANDA meetings under GDUFA III and how they can benefit preparation of ANDA submission. Learn directly from the experts and register today!
Do you work in the generic drug industry? Then don’t miss next week’s “Facilitating Generic Drug Product Development: Product-Specific Guidances” webinar. Learn from experts about the latest developments in ANDA submission, regulator review, bioequivalence, and clinical research coordination. Register early!
CDER Small Business and Industry Assistance (SBIA) reposted this
This CDER Conversation, Christopher Diamant, J.D., regulatory counsel, Office of Medical Policy, discusses how the Patient Medication Information proposed rule could help provide patients with clear instructions to help them take their medications as intended: https://lnkd.in/edV66KcE
Have you registered? Don't miss this chance to hear from the experts about developments in risk assessment, safety, and analysis: https://lnkd.in/eA2pqfXh Mat Soukup
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CDER Small Business and Industry Assistance (SBIA) reposted this
Today, we launched the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally: https://lnkd.in/eKRvHYju C3TI will be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the efficiency of drug development.
Have input on science & research specific to generic drugs? Join FDA in-person or virtually for the Fiscal Year 24 Generic Drug Science and Research Initiatives Public Workshop on May 20-21, 2024. Learn more & Register ️➡️ https://lnkd.in/eFUNb3Cj Topics discussed during the workshop will focus on research that is needed to address scientific knowledge gaps and associated challenges impacting the development and regulatory assessment of generic products, including complex generics.
Questions about Model Master Files (MMFs)? Similar to drug master files, MMFs can be referenced by multiple applications for a similar purpose of use, thus improving model sharing, model standardization, and regulatory consistency and efficiency. Join FDA and the Center for Research on Complex Generics for the “Considerations and Potential Regulatory Applications for a Model Master File” hybrid workshop on May 2-3, 2024. The workshop will discuss the concept, contexts of use, and operational aspects of MMFs, and illustrate how MMFs can make it easier the incorporate modeling and simulation during product development and to make regulatory assessment more efficient. Learn more & Register: https://lnkd.in/erCUuMm8