RAPS Philadelphia Chapter’s Post

Just a reminder to join me and Executive Editor Fran DeGrazio this week on September 26 as we welcome combination product regulatory and device experts Susan Neadle and Alan Stevens in a discussion of the new FDA guidance on Essential Drug Delivery Outputs. #drugdelivery, #combinationproducts, #fda, #eddo, #medicaldevices

📺 Watch "Navigating the FDA DHT Guidance: Perspective from Across the Industry" on-demand! View here ▶️ https://hubs.la/Q02Rp4VJ0 The panel started with a review of the FDA guidance that serves as a framework for the development, assessment, and implementation of DHTs in clinical trials, then dove into discussion on key topics including - 🔶 considerations for the multidisciplinary approach to DHT integration 🔶 how the DHT guidance fits into the drug development regulatory landscape 🔶 practical advice and resources for developing verification and validation evidence 🔶 lessons learned and planning for technology advancements #DigitalHealthMonthly #FDAGuidance #DHT #Regulatory #ClinicalTrials

If you missed our recent webinar taking you through the IND preparation process, explaining de-risking activities that save time and cost while promoting quick advancement of your product into the clinic, you can access the free webinar recording here👇 This webinar is designed to provide a plan of action that can help to de-risk your Investigational New Drug (IND) application and expedite the path to gaining study clearance. Dr. Nick Meyers, Vice President of Product Development and Katy Rudnick, Head of US Regulatory Affairs, will take you through the planning, strategy, timing, content, and delivery of the IND to help you avoid unnecessary delays to your development program. @BioPharma Connections #IND #InvestigationalNewDrug #Webinar

Choose the right regulatory pathway in the complicated landscape of drug-device combinations. Explore both EU & US options in our online training focused on quality and regulatory requirements for drug-device combination products. Find out more on the link in the comments. #drugdevelopment #medicaldevices #combinationproducts #MDR #onlinetraining

CMC, how we bring the product to GMP 👨🔬💊 In our recent internal seminar titled "CMC: How We Bring the Product to GMP," our colleagues Raquel Roman, Process Development Manager, Adrián Ferri, Control Development Manager, and Eva Martínez Judas, Drug Product Process Development and Manufacturing Manager, led an enlightening discussion on the essential steps and processes involved in bringing a product to the level of maturity necessary for entry into GMP facilities. From team structures to regulatory pathways, and quality requirements to real-world case studies, they covered it all. We delved into the intricacies of drug development processes, emphasizing the crucial milestones that pave the way towards GMP readiness. Through practical examples, we explored how Curapath has assisted various clients in achieving their goals, successfully navigating manufacturing challenges, and progressing to the next crucial stages of drug development. Thank you to Raquel, Adrián, and Eva for sharing their expertise and insights! Let's continue to learn and grow together as we pave the path for innovative healthcare solutions. #Curapath #CMC #GMP #DrugDevelopment #HealthcareInnovation #SeminarHighlights

Another APPROVAL is in the BAG! 🎉 Our team of Regulatory Affairs experts has secured yet another #HappyClient with a successful ANDA (Abbreviated New Drug Application) approval! ANDA approvals can be challenging, but with the PharmaLex team, success is within your grasp. Congratulations to Karen Harbor on her 5th ANDA approval! Is this journey in your future? 🚀 Learn more about how PharmaLex can help you in your drug or device development here: https://lnkd.in/ePaZ3HgH Sign up for our newsletter here: https://lnkd.in/ejiXKmbd Book a meeting with one of our experts to discuss your project here: https://lnkd.in/e4qDZY5u #PharmaLex #PharmaLexUS #RegulatoryAffairs #ANDAApproval #PharmaSuccess #DrugDevelopment #MedicalDevices

The use of the TPP to develop a therapeutic product is an interesting concept. Therapeutic products don't follow design controls (as medical devices do) so there needs to be some method to set design requirements up front for therapeutic products. From the medical device perspective a TPP might be viewed as "design controls lite".

As promised, here's part 2 of a two-part article series by our executive editor Fran DeGrazio. In this installment of her Frankly Fran column, Fran takes a deep dive into particle testing to illustrate her take on drug product quality. #drugdelivery, #combinationproducts, #qualityassurance, #regulatory, #particleanalysis https://lnkd.in/dvkFUWeH

Assessing the Clinical Service & Revenue Issues of the LDT Rule Clinical labs must understand cost-benefits of their LDT offerings as they prepare for FDA compliance BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical laboratories will have to comply with the U.S. Food and Drug Administration’s (FDA) new final rule regarding laboratory developed tests (LDTs). To do so, many laboratories will need to take a hard look at their current LDT offerings, with an eye toward which ones are most likely to generate revenue. They will also have to think more strategically about how they deploy LDTs and how they position themselves in the marketplace. That’s the word from Valerie Palmieri, CEO and founder of Momentum Consulting, which advises manufacturing and services. Read The Dark Report article now! https://hubs.ly/Q02QtYYZ0

Our newest blog written by regulatory affairs experts Paula Guerra and Santa Al Antwan, MBS is officially live. Linked below, they explain the importance of IND and CTA applications for developing a concise drug development strategy. ➡️ https://hubs.la/Q02CCPS40 - #IND #CTA #CTAApplication #INDApplication #DrugDevelopmentStrategy #RegulatoryStrategy