CDER Small Business and Industry Assistance (SBIA)

??Now OPEN!! SBIA’s Annual FDA Clinical Investigator Training Course (CITC) - December 10 -12, 2024. Register early!! ??https://lnkd.in/eX7b83PY

?? Coming December 10-12! SBIA's annual FDA Clinical Investigator Training Course (CITC) 2024 The primary goal of CITC is to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care. ?? Don't miss out, register today! https://lnkd.in/eX7b83PY

?? Today! SBIA | M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance In this webinar, FDA experts will provide an update and overview on the final M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms guideline including major changes from the draft guideline and FDA’s current bioequivalence (BE) guidance, delineate FDA’s planning on the implementation of M13A, and address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline. ?? Be sure to log in early! https://lnkd.in/emFF_afy

?? Tomorrow! SBIA | M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance In this webinar, FDA experts will provide an update and overview on the final M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms guideline including major changes from the draft guideline and FDA’s current bioequivalence (BE) guidance, delineate FDA’s planning on the implementation of M13A, and address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline. ?? There's still time to register! https://lnkd.in/emFF_afy

Do you submit generic drug applications or do you consult for the generic drug industry? Register now for this week’s ICH M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms webinar. The webinar on Thursday November 21 from 1-3 PM will: ???????Provide an overview of the final guideline and major changes from the draft guideline ????Provide clarifications and explain scientific thinking on selected topics in M13A and the Q&A document ?????Delineate FDA’s implementation of M13A for generic drug applications including product-specific guidance revisions Get a head start after you register at https://lnkd.in/emFF_afy by reading the Guidance document below:

Artificial Intelligence (AI) technology holds great promise for pharmacovigilance. FDA wants to engage with industry and relevant stakeholders via the Emerging Drug Safety Technology Meeting Program to facilitate discussion and mutual learning about the application of AI to pharmacovigilance. Learn more in our latest podcast with Dr. Robert Ball, Deputy Director of the Office of Surveillance and Epidemiology at https://lnkd.in/evU5suUe, or read the transcript at https://lnkd.in/eA_PFHHy.

?? Test your knowledge in anticipation of our December 10-12 SBIA | FDA Clinical Investigator Training Course (CITC) 2024 conference by responding to the question below. The answer will be posted once the poll closes. ?? Be sure to register! https://lnkd.in/eX7b83PY Question: Which of the following is NOT a primary responsibility of a clinical investigator? A.??Ensuring the safety and well-being of trial participants B.??Maintaining accurate and complete trial records C.??Conducting statistical analysis of trial data D.??Obtaining informed consent from trial participants

?? Next week! Join us Nov. 21 for SBIA | M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance In this webinar, FDA experts will provide an update and overview on the final M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms guideline including major changes from the draft guideline and FDA’s current bioequivalence (BE) guidance, delineate FDA’s planning on the implementation of M13A, and address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline. ?? Don't miss out! https://lnkd.in/emFF_afy

?? December 4! SBIA | Clinical Pharmacology Considerations for Novel Therapeutic Modalities Webinar The webinar will discuss the unique considerations for oligonucleotide therapeutics and antibody-drug conjugates, including final guidances, with respect to topics such as dose selection, exposure/response analysis, organ impairment, drug interactions, QTc assessment, and immunogenicity. ?? Have you registered yet? https://lnkd.in/d-asxqj2

?? Today! Join SBIA for Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies webinar This webinar will discuss the final guidance for the industry?Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies?which was published in July 2024. Our FDA subject matter experts will also address recommendations from the guidance including, deciding whether and when to conduct the study, as well as how to design and report results from a human radiolabeled mass balance study. ?? Log in early! https://lnkd.in/e9NWduyB