How to streamline MLR submissions for compliance

Delivering a high-priority FDA submission requires precision, collaboration, and calm under pressure. Boyds’ Regulatory Operations team partnered with a global healthcare company to deliver a complex, time-critical FDA submission - on time and in full compliance. Our latest case study highlights how expert planning, eCTD compliance, and seamless teamwork ensured regulatory excellence when it mattered most. Read the full case study: https://lnkd.in/eC3KYa8b If you require Regulatory Operations support for your next submission, our expert team can help you plan, publish, and deliver with precision. Get in touch at info@boydconsultants.com. #FDAsubmission #RegulatoryOperations #eCTD #DrugDevelopment 

Delivering complex, time-critical FDA submissions is a high-pressure challenge. This case study perfectly illustrates how an experienced and knowledgeable Regulatory Operations team can make all the difference. It shows that strategic planning and robust processes are essential for success.

If you work in pharma, medical affairs, or regulatory, understanding the difference between these two enforcement tools is essential. Both signal compliance risk but they carry very different weight. What is an FDA Untitled Letter? An Untitled Letter (sometimes called an “Notice of Violation”) is issued when the FDA identifies a potential regulatory concern — often involving misleading promotional claims, labeling issues, or unsubstantiated statements — that do not yet warrant a formal enforcement action. Think of it as an early warning. It flags the issue and asks the company to correct it voluntarily. What is a Warning Letter? A Warning Letter is more serious. It’s a formal notification that the FDA has determined a significant regulatory violation that requires prompt corrective action. Warning Letters are public, often cited in media or investor reports, and can affect product approvals or inspections if unaddressed. Key distinctions: • Severity: Untitled = potential violation, Warning = confirmed significant violation. • Tone: Untitled requests voluntary correction; Warning demands a written response with a remediation plan. • Public visibility: Warning Letters are posted to FDA’s website; Untitled Letters may or may not be. • Implications: Ignoring an Untitled Letter can escalate to a Warning Letter or further enforcement. For professionals in Medical Information, Regulatory, or Medical Affairs, understanding these distinctions helps ensure your communications remain compliant, transparent, and scientifically balanced. Misrepresentation of data, omission of risk, or unsubstantiated claims, even unintentionally, can trigger an FDA review. #MedicalInformation #MedicalAffairs #PharmaCompliance #PharmaceuticalIndustry #LifeSciences #CareerPivot —— 🔔 Follow me here on LinkedIn for clear, concise insights into leadership and the life science space! 📩 Subscribe to the Med Info Monthly newsletter for deeper dives into topics important to the medical information space.

'The Regulatory Accelerator consists of three components: a resource index for applicants with a visual guide of FDA tools, opportunities for engagement, and relevant guidance documents; a medical device software guidance navigator to help applicants find relevant FDA guidances for their submission; and the early orientation meeting program.' I quite like this initiative of regulatory accelerator and I hope it will be successful. The idea of having 'meeting' with the regulatory agencies at any stage could be quite intimidating for smaller companies which do not have much experience of interacting with regulators. #regulatoryaffairs #FDA #pharma #clinicalresearch https://lnkd.in/ek8XViW2

FDA published draft guidance on the type of information medical device submissions need for their Quality Management System documentation to incorporate changes from when FDA aligned to international standard ISO 13485. https://lnkd.in/eRSuAHaX #MedicalDevices #ManufacturingQuality #medicalmanufacturing #qms

Regulatory updates: NMPA: Announcement on the Issuance of the Medical Device Good Manufacturing Practice (GMP) (No. 107, 2025) To enhance quality management in medical device production, regulate manufacturing practices, foster the industry's orderly development, and safeguard public health by ensuring the safety and effectiveness of medical devices, the NMPA has revised the Medical Device Good Manufacturing Practice (GMP) pursuant to the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Production. The revised GMP is here by promulgated and shall come into effect on November 1, 2026. Concurrently, the previous Announcement on the Issuance of the Medical Device Good Manufacturing Practice (No. 64, 2014) issued by the former China Food and Drug Administration is hereby repealed. if you need more details, please connect with me. I am regulatory expert

🇺🇸 FDA Finalizes Guidance on Small Business Qualification Under MDUFA The U.S. Food and Drug Administration (FDA) has issued its final guidance (July 2025) updating the 2018 document on Medical Device User Fee Small Business Qualification and Certification. 📌 Key updates: Clarifies how FDA will determine financial hardship for small businesses seeking a waiver of the establishment registration fee Details acceptable documentation—including from entities in jurisdictions without a national taxing authority Introduces Form 3602N, replacing Forms 3602 and 3602A with a single consolidated form for streamlined submission 💰 Under the Medical Device User Fee Amendments (MDUFA): Businesses with ≤ $100M in gross receipts may qualify for reduced application fees Those with ≤ $30M may receive a waiver for the first premarket application/report fee Entities with ≤ $1M and demonstrated hardship may qualify for a registration fee waiver This guidance provides a clearer pathway for small and emerging manufacturers to access regulatory support while maintaining compliance. At TS Quality & Engineering, we partner with medical device and IVD manufacturers to navigate FDA requirements, optimize documentation, and accelerate market access. 📩 Contact us: info@tsquality.ch #FDA #MedicalDevices #MDUFA #RegulatoryAffairs #MedTech #HealthTech #LifeSciences #MedicalDeviceRegulation #MedicalDeviceIndustry #Compliance #RegulatoryCompliance #MedicalInnovation #Biotech #HealthcareRegulation #TSQualityEngineering

🇺🇸 FDA Finalizes Guidance on Small Business Qualification Under MDUFA The U.S. Food and Drug Administration (FDA) has issued its final guidance (July 2025) updating the 2018 document on Medical Device User Fee Small Business Qualification and Certification. 📌 Key updates: Clarifies how FDA will determine financial hardship for small businesses seeking a waiver of the establishment registration fee Details acceptable documentation—including from entities in jurisdictions without a national taxing authority Introduces Form 3602N, replacing Forms 3602 and 3602A with a single consolidated form for streamlined submission 💰 Under the Medical Device User Fee Amendments (MDUFA): Businesses with ≤ $100M in gross receipts may qualify for reduced application fees Those with ≤ $30M may receive a waiver for the first premarket application/report fee Entities with ≤ $1M and demonstrated hardship may qualify for a registration fee waiver This guidance provides a clearer pathway for small and emerging manufacturers to access regulatory support while maintaining compliance. At TS Quality & Engineering, we partner with medical device and IVD manufacturers to navigate FDA requirements, optimize documentation, and accelerate market access. 📩 Contact us: info@tsquality.ch #FDA #MedicalDevices #MDUFA #RegulatoryAffairs #MedTech #HealthTech #LifeSciences #MedicalDeviceRegulation #MedicalDeviceIndustry #Compliance #RegulatoryCompliance #MedicalInnovation #Biotech #HealthcareRegulation #TSQualityEngineering

FDA Accelerates Drug Reviews — What It Means for Regulatory Affairs and Field Force Teams  Last week, the FDA announced a new group of candidates for fast-track review. For Regulatory Affairs professionals, this is a strong signal: shorter review cycles are reshaping not only regulatory timelines — but also how companies plan their market access and communication strategies. While regulators move faster, Field Force teams must be ready to adapt — updating materials, refining medical messaging, and aligning closely with RA departments. At ALPI Solutions, we see that the integration of Regulatory Affairs + Field Force is becoming a core strategic driver — especially in the era of GLP-1 therapies and personalized medicine. Speed, unified communication, and regulatory compliance are no longer advantages — they’re the new standard for 2025. #RegulatoryAffairs #FieldForce #FDANews #PharmaTrends #MarketAccess #AlpiSolutions

Every week brings new regulatory updates — this time, FDA’s fast-track decisions remind us: agility isn’t optional anymore. It’s the foundation of effective pharma communication.