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Navigating FDA Advisory Committee meetings is an important step in the drug approval process for certain medications. These independent expert panels provide recommendations on the safety and efficacy of new medications. In our latest NDA Insight article, we introduce FDA Advisory Committee meetings, including why they are scheduled, what is expected of drug developers, and key factors for success. Learn how to prepare for these meetings, develop a clear and concise presentation, and anticipate potential questions from the committee. Our PharmApprove team at NDA has successfully prepared hundreds of client teams for high-stake interactions with regulatory bodies. Let us help you succeed. Click on the link to learn more:https://lnkd.in/e4-4ndAp #FDA #DrugApproval # #DrugDevelopment #FDAApproval #RegulatoryCompliance #DrugSafety

📢 FDA has released an updated guidance on charging for investigational drugs, and it's important news for sponsors who are authorized to charge for these drugs. The updated guidance now allows sponsors to recover costs related to manufacturing, administration, and monitoring. It also recommends the need for an independent certified public accountant to verify the charges. The guidance provides criteria for authorizing charging for an investigational drug in a clinical trial, expanded access use, and determining costs that can be recovered. These changes represent a significant update compared to the 2016 version. If you're involved in clinical trials or expanded access use, it's essential to stay informed and check out the updated guidance today! #FDA #investigationaldrugs #clinicaltrials #expandedaccess

The introduction of #mdr has significantly increased the importance of #clinicalevaluation for #medicaldevices. And whilst several guidelines exist on clinical evaluation under MDR, many manufacturers are often still unsure of how to interpret the rules for providing sufficient clinical evidence for their medical devices. In particular, Article 61(10) of the MDR which addresses clinical evaluation based on non-clinical testing methods alone, is becoming increasingly relevant, presenting challenges for manufacturers and notified bodies. Brought to you in collaboration with our esteemed #clinicalaffairs partner, Dr. med. Holger Anhalt, our latest topical article outlines the different #regulatory and clinical strategies related to determining adequate clinical evidence, and offers some practical advice based on our extensive clinical experience in the #medicaldevice and pharmaceutical industry. At the link below, you can find out more about: 🔎 Identifying the benchmarks for pivotal clinical data 📑 Clinical vs. non-clinical data provision under MDR | Article 61(1) vs. Article 61(10) 📝 What to include in your clinical evaluation plan and clinical evaluation report regarding clinical evidence https://lnkd.in/dxs7P6rr

Interesting case study where Allucent provided strategic guidance for a client's unique and complex New Drug Application (NDA) with multiple indications. The company faced a significant challenge when the FDA’s assessment deemed their initial studies did not conform with new regulatory guidelines, which were newly introduced after the conduct of the studies. Learn more about the strategy for our client's NDA submission where they received approval for all indications, including pediatric patients, marking a significant milestone in the client’s journey and securing them 10 years of market exclusivity. You can read the Case Study here: https://lnkd.in/gnmzCnQ9   #FDA #RegulatoryStrategy #RegulatoryAffairs #NewDrugApproval #ClinicalDevelopment #ClinicalResearch #ClinicalTrials #InfectiousDiseases

ARC Regulatory Latest Blog - Are you ready to ensure the success of your IVD development and bring your product to market? Partnering with a Contract Research Organization (CRO) might be the key. A CRO provides clinical study management services for pharmaceutical, biotech, and medical device companies. They offer comprehensive support throughout the clinical study process, from study design to regulatory compliance and data management. A CRO, can significantly influence the success of your clinical trial but it’s crucial to select one that aligns with your project's specific requirements and can navigate the complexities of clinical research with confidence. Read our expert Amanda Ball latest blog where she explains what is a CRO, why do you need one, and how to choose the right one for your organization and project - What is a Contract Research Organisation (CRO) and why do you need one https://bit.ly/3YwlrO0 Stay up to date with the ever-changing regulatory landscape by signing up to our mailing list here: https://bit.ly/3YyCsHt #FDA #LDT #RegulatoryCompliance #ClinicalTrials #MedicalDevices #ARCRegulatory #Regulations #IVD #CRO

Did you know FDA Center for Biologics Evaluation and Research maintains a list of virtually all Clinical Investigators who have been inspected? This list contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER). These inspections were conducted as part of the Food and Drug Administration's Bioresearch Monitoring Program. This list contains information on inspections that were closed after 1989. #fda #cber #ora #gcp #clinicalresearch #clinicaltrial

+ + + News on EU Regulatory Affairs of Pharma and Medicines + + + European Medicines Agency EMA updates guideline for combination products of medicinal products (pharmaceuticals) combined with medical devices and IVDs (CDx) - the regulatory frameworks MDR and IVDR, 726/2004, Manufacturers, Notified Bodies and Competent Authorities assure Safety, Quality and Compliance in a dual framework setting - In case there is a combination in the intended use or use scenario. #EMA #Pharma #Medicines #NCA #Medicines #MedicalDevices #CDx

Today FDA released guidance on Use of Data Monitoring Committees in Clinical Trials This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB), a data and safety monitoring committee (DSMC), or an independent data monitoring committee (IDMC)) would be useful for trial monitoring and what procedures and practices should be considered to guide their operation. When finalized, this guidance will supersede the final guidance for clinical trial sponsors entitled "Establishment and Operation of Clinical Trial Data Monitoring Committees," issued in March 2006. #clinicaltrials #clinicalresearch #datamonitoring #clinicaldevelopment #clinicaldatamanagement #fda #pharmacology #researchanddevelopment #pharmaceuticalsciences

e-Lesson of the day: NEW DRUG DEVELOPMENT AND CLINICAL TRIALS This module describes the most important characteristics of drug products and explains why the development and testing of new drug products must be regulated. It provides an overview of the drug development process and the various phases of clinical trials. It also introduces the concept of Good Clinical Practice (GCP). Follow SKILLPAD - digital learning for life sciences on LinkedIn at https://lnkd.in/ejd-z5Am for more news and updates. NEW DRUG DEVELOPMENT AND CLINICAL TRIALS learning objectives, description and screenshots here: https://lnkd.in/g_yXaJ_d Schedule a DEMO by contacting info@skillpad.com #pharma #pharmaceuticals #clinicaltrials #gcp

Hello connection, I recently completed a certified course in Good Clinical Practice (GCP) conducted by the NIDA Clinical Trial Network, enhancing my expertise in ICH GCP guidelines. This course equips me with the knowledge to ethically and effectively conduct clinical research, ensuring participant safety and data integrity. Excited to apply these skills to contribute effectively to the healthcare and pharmaceutical sectors. #GCP #ClinicalResearch #ClinicalTrials