Boyds’ Post

𝐀 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐅𝐥𝐞𝐱𝐢𝐛𝐢𝐥𝐢𝐭𝐲: 𝐄𝐧𝐡𝐚𝐧𝐜𝐢𝐧𝐠 𝐅𝐚𝐜𝐢𝐥𝐢𝐭𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 The FDA has finalized the facility readiness guidance (with no major changes from its draft version published in October 2022). By offering more time for facilities to achieve compliance with current good manufacturing practices (cGMP), the FDA aims to streamline the approval process and reduce delays caused by facility readiness issues. Under the Generic Drug User Fee Amendment (GDUFA III), sponsors of abbreviated new drug applications (ANDA) can receive a 15-month extension to bring non-compliant facilities up to standard. 𝘈𝘴 𝘴𝘵𝘢𝘵𝘦𝘥 𝘪𝘯 𝘵𝘩𝘦 𝘨𝘶𝘪𝘥𝘢𝘯𝘤𝘦, 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯𝘴 𝘴𝘵𝘪𝘭𝘭 𝘯𝘰𝘵 𝘳𝘦𝘢𝘥𝘺 𝘧𝘰𝘳 𝘪𝘯𝘴𝘱𝘦𝘤𝘵𝘪𝘰𝘯 30 𝘥𝘢𝘺𝘴 𝘣𝘦𝘧𝘰𝘳𝘦 𝘵𝘩𝘦 15-𝘮𝘰𝘯𝘵𝘩 𝘨𝘰𝘢𝘭 𝘥𝘢𝘵𝘦 𝘸𝘪𝘭𝘭 𝘩𝘢𝘷𝘦 𝘵𝘩𝘦𝘪𝘳 𝘢𝘴𝘴𝘦𝘴𝘴𝘮𝘦𝘯𝘵 𝘨𝘰𝘢𝘭 𝘳𝘦𝘴𝘦𝘵 𝘣𝘺 𝘢𝘯 𝘢𝘥𝘥𝘪𝘵𝘪𝘰𝘯𝘢𝘭 15 𝘮𝘰𝘯𝘵𝘩𝘴. 𝘛𝘩𝘪𝘴 𝘮𝘦𝘢𝘯𝘴 𝘢 𝘵𝘰𝘵𝘢𝘭 𝘱𝘰𝘵𝘦𝘯𝘵𝘪𝘢𝘭 𝘥𝘦𝘭𝘢𝘺 𝘰𝘧 30 𝘮𝘰𝘯𝘵𝘩𝘴, 𝘦𝘮𝘱𝘩𝘢𝘴𝘪𝘻𝘪𝘯𝘨 𝘵𝘩𝘦 𝘪𝘮𝘱𝘰𝘳𝘵𝘢𝘯𝘤𝘦 𝘰𝘧 𝘦𝘢𝘳𝘭𝘺 𝘤𝘰𝘮𝘱𝘭𝘪𝘢𝘯𝘤𝘦. While this extension is a positive step, it’s 𝘯𝘰𝘵 a blanket solution. The FDA has clarified that certain applications, particularly those involving 𝘣𝘪𝘰𝘦𝘲𝘶𝘪𝘷𝘢𝘭𝘦𝘯𝘤𝘦 𝘢𝘯𝘥 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘴𝘵𝘶𝘥𝘺 𝘧𝘢𝘤𝘪𝘭𝘪𝘵𝘪𝘦𝘴, 𝘰𝘳 𝘵𝘩𝘰𝘴𝘦 𝘵𝘩𝘢𝘵 𝘩𝘢𝘷𝘦 𝘢𝘭𝘳𝘦𝘢𝘥𝘺 𝘳𝘦𝘤𝘦𝘪𝘷𝘦𝘥 𝘤𝘰𝘮𝘱𝘭𝘦𝘵𝘦 𝘳𝘦𝘴𝘱𝘰𝘯𝘴𝘦 𝘰𝘳 𝘵𝘦𝘯𝘵𝘢𝘵𝘪𝘷𝘦 𝘢𝘱𝘱𝘳𝘰𝘷𝘢𝘭 𝘭𝘦𝘵𝘵𝘦𝘳𝘴, 𝘢𝘳𝘦 𝘯𝘰𝘵 𝘦𝘭𝘪𝘨𝘪𝘣𝘭𝘦 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘥𝘦𝘧𝘦𝘳𝘳𝘢𝘭. This nuanced approach ensures that the focus remains on facilities crucial to the premarket application process. #FDA #Generics #GenericDrugs #RegulatoryAffairs #DrugApproval #FacilityReadiness #ANDA

CTR Implementation - a QP’s perspective The CTR is the most impactful regulatory development on Clinical Trials and IMPs in the EU for decades. The transition from CTD to CTR is coming to an end soon, we are working hard to switch all trials, and we observe several challenges while exploring unchartered terrain. If you are interested in a QP’s perspective on the matter, please have a look at my publication in the GMP Journal. Thanks a lot to my colleagues at the GQPA and at Roche who contributed, supported, reviewed, and made this possible. My perspective is obviously QP-specific and subjective. You may have come to different conclusions and we all learn from listening to different views. You are invited to leave a comment and share your thoughts. #CTR #QP #IMPs #GQPA #Roche https://lnkd.in/ePurvieG

They say don't boil the ocean...but in order to solve your biggest, most complex problems, you must boil the ocean. Orca1 continues to distill the life sciences data ocean down to its most concise and impactful form. #FDA #RegulatoryAffairs #Pharma #MedicalDevices #QualityAssurance

Orca1 now offers instant, low-cost access to a vast collection of 85,000+ FDA FOIA documents (across all product types), including 483s, 483 responses, EIRs, device submissions, drug applications, and more. Users can even perform full-text searches across all documents. This level of access to these documents unlocks critical insights for regulatory submissions, quality assurance, inspections, competitive intelligence, risk assessment, due diligence, and more. Normally, it costs hundreds or thousands of dollars to obtain one of these documents through other services or directly through the FDA, potentially with a waiting period. With Orca1, you'll save your company valuable time and money. Orca1 Pricing: - Device submissions: $99.99 - 483s: $9.99 - EIRs: $29.99 - Investigator Profiles: $19.99 Industry Pricing: - Device submissions: $200 to $3500 - 483s: $200 to $400 - EIRs: $400 to $1200 - Investigator Profiles: $700 to $3000 + Drug applications and other drug information are coming soon! Sign up for instant access at: https://orca1.ai #FDA #RegulatoryAffairs #LifeSciences #FDAApproval #QualityAssurance #Pharma #MedicalDevices #EnforcementActions #GMP #MedTech #Compliance

📌 Q&A document released | PRIME/ Breakthrough Therapy Applications ▶ The European Medicines Agency and the US FDA have released a #Q&A document about #Quality and #GMP aspects linked to their respective programmes, #PRIME and #BreakthroughTherapyDesignation, that are aimed at expediting the #development of #innovativemedicines that address unmet #medicalneeds.  ▶ Even with expedited processes, these programmes require #comprehensive #clinical, #nonclinical, and #chemistry, #manufacturing, and control (#CMC) information to meet #approvalstandards. ↪ Following the #workshop and continued #discussions, EMA and FDA/CDER prepared four #Q&A documents to compile their current thinking on these topics:  Q&A on #Controlstrategyconsiderations for PRIME/BT #applications  Q&A on #Processvalidation approaches for PRIME/BT applications  Q&A on #Alternatives for determination of #retest period or #shelflife for PRIME/BT applications  Q&A on #GMPconsiderations for PRIME/BT applications  ▶ They reflect the consensus from existing #guidance documents and are presented as annexes to the workshop report. 📖 Read the complete new here: https://bit.ly/48Zpg0Q 📧 Contact us to schedule a meeting to discuss how this new document may affect your company: info@asphalion.com #guidance #EMA #FDA #PRIME #Breakthrough #Q&A #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience  

Delighted to have attended and completed the SBIA Regulatory Education for Industry (REdI) Conference, hosted by the Center for Drug Evaluation and Research (CDER). This experience has significantly broadened my understanding of industry standards and regulatory processes. #RegulatoryAffairs #ProfessionalDevelopment #IndustryEducation

A great & important Friday read! #RWE to support #regulatory submissions. Thank you, Mehmet Burcu for sharing! https://lnkd.in/eHuiT8TJ #regulatory #regulatoryaffairs #clinicaltrials #EMA #access #marketaccess #realworldevidence #realworlddata #rwd #predictiveanalytics #pharma #medicalaffairs #heor #healtheconomics #patientaccess #raredisease #acceleratedapproval #observational #registries #safety #realworldoutcomes #RCT #clinicalpharmacology #FDA

Health Canada have announced the update of eCTD validation rules for regulatory transactions, aligning with recent process changes.  The rules are built in accordance the information provided in the following documents: ・Guidance Document - Preparation of Drug Regulatory Activities in　Electronic Common Technical Document (eCTD) Format; ・Creation of the Canadian Module 1 Backbone (eCTD) format - Guidance Document ・International Council for Harmonisation (ICH) Electronic Common Technical Document Specification (Version 3.2.2) ・Guidance Document: The Regulatory Enrolment Process (REP) 📚 Key Updates: Version: 5.2 Effective Date: May 1, 2024 Summary of Changes: ・Added Master File (MF) XML to I02, I03, I06, I07, I08 ・Updates to B32, B44, B47, B48 (logic unchanged) ・Added searchable documents to B49 ・I09 - Changed dash to underscore ・I11 - Added version of RT XML and MF XML files Have questions or need clarification? Visit Health Canada website or email at ereview@hc-sc.gc.ca #ectd #regulatoryaffairs #regulatoryoperations #pharmaceutical #pharmaceuticalindustry #pmda #fda #edqm #ema #publishingservices #swissmedic #tga #healthcanada #incountrycaretaker #solutions #globalregulatory #ectdpublishing

💊 ✅ Join Premier Consulting's webinar on 505(b)(2) drug development! Understanding pathways like 505(b)(1), 505(b)(2), and 505(j) is crucial for bringing new medications to market.The 505(b)(2) pathway offers market exclusivity and patent protection. To maximize its potential, an aggressive development strategy and seamless communication among regulatory, CMC, nonclinical, commercial, and clinical teams are essential. This session will explore the 505(b)(2) strategy. The expert speakers will guide you through developing a robust plan and highlight the importance of a multidisciplinary approach. 🔍 Learn more + register here: https://buff.ly/3wLIj0v 🌟 Featured speakers: William S. Seth D. DePuy, Ph.D. #DrugDevelopment #DrugApproval #DrugDiscovery #DrugSafety #FDAApproval #NewDrugApproval #InvestigationalNewDrug #Regulatory #FDAGuidance

Uncover the power of SEND datasets in FDA compliance and drug development quality! In this guide, SEND Datasets FDA: Enhancing Compliance and Quality in Drug Development, you will learn how SEND datasets elevate your regulatory compliance game and ensure top-notch quality in drug development. Access the guide now and take your processes to the next level. https://hubs.la/Q02Dc7c70