Paul Martinetti, MD’s Post

Navigating the regulatory landscape? Our team is here to help. Check out the Bracken FDA Meeting Request Calculator which will help you plan and understand the necessities for your unique project. https://lnkd.in/eBCm_Ncq #FDAMeetings #RegulatoryAffairs #LifeSci #Bracken

Seeking FDA approval? The regulatory process is complex, but we've got you covered. Bracken's FDA Meeting Request Calculator serves as your ultimate tool for navigating the regulatory pathway with precision and confidence. Gain invaluable insights into the timing and steps necessary to secure that crucial FDA meeting, tailored to your project's unique timeline. Regulatory journeys can vary, but with the meeting calculator and its accompanying robust checklist, you'll be on the road to success. Try it today: https://lnkd.in/gtVmjWWX #FDAMeetings #RegulatoryAffairs #LifeSci #Bracken

Seeking FDA approval? The regulatory process is complex, but we've got you covered. Bracken's FDA Meeting Request Calculator serves as your ultimate tool for navigating the regulatory pathway with precision and confidence. Gain invaluable insights into the timing and steps necessary to secure that crucial FDA meeting, tailored to your project's unique timeline. Regulatory journeys can vary, but with the meeting calculator and its accompanying robust checklist, you'll be on the road to success. Try it today: https://lnkd.in/gkNduWF3 #FDAMeetings #RegulatoryAffairs #LifeSci #Bracken

Seeking FDA approval? The regulatory process is complex, but we've got you covered. Bracken's FDA Meeting Request Calculator serves as your ultimate tool for navigating the regulatory pathway with precision and confidence. Gain invaluable insights into the timing and steps necessary to secure that crucial FDA meeting, tailored to your project's unique timeline. Regulatory journeys can vary, but with the meeting calculator and its accompanying robust checklist, you'll be on the road to success. Try it today: https://lnkd.in/dTjaun62 #FDAMeetings #RegulatoryAffairs #LifeSci #Bracken

I'm excited to announce our new service line: #CoPilotComprehension. This innovation represents nearly a decade of dedication to my life's passion, robust #SurveyMethodology, applied to a cause that truly matters—enhancing healthcare communication. #MedicalDeviceManufacturing #humanfactorstudies #UserComprehensionStudies #FDAclearance

When responding to FDA 483 observations that you believe are inaccurate, your response should always provide the facts and explanation needed to explain why the observation is not wholly accurate. You should always support your claims and response to 483 observations with facts and data. Avoid unsupported, unexplained assertions because they are of no value to the FDA's analysis of the response.

During an inspection, FDA investigators may observe conditions they deem to be objectionable. These observations are listed on an FDA Form 483. If you do not manage it appropriately it can turn into a significant issue (warning letter), significant issues can become a consent decree which is a pre-negotiated injunction. You do not need to be the best; you just need to be the right one. The right consult can do good things but together we can obtain remarkable results. Let us be proactive.

For my Laboratory Developed Test people...with the FDA moving ahead on implementing its LDT rule, FDA regulators recently offered insight into how they expect to enforce laboratory registration under the rule. In a Dec. 3 webinar, staff clarified their view of what it means to be a “single entity;” the event came as the agency continues to develop its system for granting waivers from the annual establishment registration fee. See the AgencyIQ analysis below! Laura DiAngelo

Focused sessions, interactive discussions, and regulatory updates all here at the 33rd Annual PDA FDA Joint Meeting in Washington DC today. Stop by and chat with our team. How can we help you meet your 2024 goals? #pdafda2024

FDA: You did not provide enough information about your algorithm Solution A: Use clear diagrams like this one we use for all our submissions. Include the diagram key on every diagram. Solution B: Just hire us to do it :). We'll build it and FDA clear it.