…The TAP Pilot is a new component of the Medical Device User Fee Amendment (MDUFA V) Agreement, which was signed into law on September 30, 2022, and reauthorized for five…
…The TAP Pilot is a new component of the Medical Device User Fee Amendment (MDUFA V) Agreement, which was signed into law on September 30, 2022, and reauthorized for five…
…and how to submit postmarket surveillance reports, including content and format of reports Evaluation of reports and possible FDA actions after completion Failure to comply Public disclosure of postmarket surveillance…
…and how to submit postmarket surveillance reports, including content and format of reports Evaluation of reports and possible FDA actions after completion Failure to comply Public disclosure of postmarket surveillance…
…their reputations, publishers can avoid publishing problematic manuscripts with mistakes and the scientific community can better ensure the integrity of future research. References: [1] https://www.economist.com/science-and-technology/2022/07/23/critical-research-on-the-causes-of-alzheimers-may-have-been-falsified [2] https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease [3] https://ukrio.org/research-integrity-resources/expert-interviews/jana-christopher-image-integrity-analyst/…
…their reputations, publishers can avoid publishing problematic manuscripts with mistakes and the scientific community can better ensure the integrity of future research. References: [1] https://www.economist.com/science-and-technology/2022/07/23/critical-research-on-the-causes-of-alzheimers-may-have-been-falsified [2] https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease [3] https://ukrio.org/research-integrity-resources/expert-interviews/jana-christopher-image-integrity-analyst/…
…on the market, provided the company commits with its notified body to complete further testing in the post-market phase as more tumor samples become available. However, “that is only in…
…on the market, provided the company commits with its notified body to complete further testing in the post-market phase as more tumor samples become available. However, “that is only in…
…benefits brought about through the use of automated systems in agriculture, emergency preparedness and health care. “This important progress must not come at the price of civil rights or democratic…
…benefits brought about through the use of automated systems in agriculture, emergency preparedness and health care. “This important progress must not come at the price of civil rights or democratic…
…systematic reviews to improve decision making, healthcare delivery and potentially patient outcomes.” This challenge competition builds on previous competitions that AHRQ has held. These challenge competitions are developed to foster…
…systematic reviews to improve decision making, healthcare delivery and potentially patient outcomes.” This challenge competition builds on previous competitions that AHRQ has held. These challenge competitions are developed to foster…
…studies and to optimize the sample sizes for both the pediatric and adult study populations.” Industry and stakeholders can submit comments on the guidance document electronically via docket ID: FDA-2013-S-0610…
…studies and to optimize the sample sizes for both the pediatric and adult study populations.” Industry and stakeholders can submit comments on the guidance document electronically via docket ID: FDA-2013-S-0610…
…Real-time communication eliminates constant uploads and downloads. More accessible data also enables greater regulatory compliance capabilities through artificial intelligence (AI), allowing regulatory teams to quickly identify delays and conduct a…
…Real-time communication eliminates constant uploads and downloads. More accessible data also enables greater regulatory compliance capabilities through artificial intelligence (AI), allowing regulatory teams to quickly identify delays and conduct a…
The FDA Center for Devices and Radiological Health (CDRH) has announced new funding opportunities to support small businesses in developing innovative medical device development tools (MDDTs). The MDDT program was…
The FDA Center for Devices and Radiological Health (CDRH) has announced new funding opportunities to support small businesses in developing innovative medical device development tools (MDDTs). The MDDT program was…
…speeding up new product introductions and complying with increased regulatory requirements. Benefits of Predictive Quality Predictive quality is a proactive and adaptive approach to build quality into processes. It combines…
…speeding up new product introductions and complying with increased regulatory requirements. Benefits of Predictive Quality Predictive quality is a proactive and adaptive approach to build quality into processes. It combines…
