Geron Corporation’s Post

Streamlining regulatory review and consensus standards in the field of in-vitro diagnostics are crucial for ensuring high-quality diagnostic access and reducing diagnostic errors. This process plays a vital role in minimizing wrong diagnoses and missed diagnoses, ultimately enhancing patient care and outcomes. #RegulatoryReview #Diagnostics #HealthcareQuality

Learn about the types of pre-ANDA meetings under GDFUA III, with specific focuses on changes and new features of pre-submission meetings. FDA experts will answer questions during a live Q&A sessions. Register today! https://lnkd.in/d5Fvtmj2

Our Regulatory experts at #OneMMS can help your organization navigate through these changes.

Thoughts on this? >> Stakeholders weigh in on potential reforms to FDA advisory committee process >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #pharmaceutical #productmarketing #healthcare #pharma

Thoughts on this? >> Stakeholders weigh in on potential reforms to FDA advisory committee process >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #pharmaceutical #healthcare #pharma #biotech

To best leverage externally controlled trials, sponsors and investigators should review the recommendations within the available FDA guidance and the information available from articles and case studies. We summarize all the recommendations for sponsors in this new brief. Learn more. https://lnkd.in/eEuB9maN

FDA drug safety communication warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. #pharmacy #independentpharmacy #FDA #antiseizure Learn more https://lnkd.in/eF-_77HV

💡 What are the key actionable lessons in designing and delivering psychedelic trials to meet regulatory standards? We went through the entire 9-hour session on the FDA AdComm's review of MDMA-assisted therapy and created a practical and actionable guide to support drug developers in meeting regulators' demands. Read here: https://lnkd.in/dD_Yjivm We'll discuss the key issues in more detail in our upcoming webinar: 🗓 2 July, 2024 @ 3 pm (UK) Registration: https://lnkd.in/e6jUVTnT #fda #adcomm #mdma #psychedelictrials #clinicalresearch #clinicaldevelopment #clinicaltrials #psychedelictherapy

The pharmaceutical and biotech industries are anxiously awaiting the specifics of the changes the US Food and Drug Administration (FDA) is expected to make to the Advisory committee meetings (AdCom) process. Join us on March 28 as we discuss some key information, including: - The potential changes to be made by the FDA to AdCom meetings - The implications of these potential changes to their business and clinical development models - The potential strategies to prepare for the coming changes to FDA Advisory Committees Register to join the discussion and ask your questions at https://buff.ly/3IJtKNC Be sure to download our guide that includes an analysis of the top five most likely changes to the FDA advisory committee system, implications to the industry, and how to be prepared. https://buff.ly/3TlxJ7N. #FDA #AdCom #FDAAdComMeetings #RegulatoryAffairs #Biotech #Pharmaceutical

The pharmaceutical and biotech industries are anxiously awaiting the specifics of the changes the US Food and Drug Administration (FDA) is expected to make to the Advisory committee meetings (AdCom) process. Join us on March 28 as we discuss some key information, including: - The potential changes to be made by the FDA to AdCom meetings - The implications of these potential changes to their business and clinical development models - The potential strategies to prepare for the coming changes to FDA Advisory Committees Register to join the discussion and ask your questions at https://buff.ly/3Tv8NLk Be sure to download our guide that includes an analysis of the top five most likely changes to the FDA advisory committee system, implications to the industry, and how to be prepared. https://buff.ly/3II95JB. #FDA #AdCom #FDAAdComMeetings #RegulatoryAffairs #Biotech #Pharmaceutical