Reducing the complexity of Regulatory submissions, the global Regulatory Authorities transformed all the submissions from paper to electronic format. Respectively, there are several electronic submission formats proposed by country-specific Regulatory bodies.
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August 26, 2020 Medical Devices -
February 28, 2020 Regulatory Affairs, Publishing & SubmissionsBeing a Member State of the European Union (EU), the Republic of Cyprus through the Department of Pharmaceutical Services has mandated the submission of the medicinal products for human use through the Common European Submission Platform (CESP).
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January 29, 2020 Medical Devices, Publishing & SubmissionsThe United States Food and Drug Administration (USFDA), to enhance the submission process for medical devices, has introduced a final rule to replace the paper submissions with electronic submissions. The rule which was proposed in September 2018 is expected to come into effect in 2020.
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December 30, 2019 Regulatory Affairs, Publishing & SubmissionsThe changing landscape of the life sciences industry makes it necessary for the companies to adapt to the global Regulatory requirements, immediately. Companies need to evolve themselves for the necessary transition with each mandatory requirement from the health authorities.
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November 28, 2019 Regulatory Software & Services, Regulatory Affairs, Publishing & SubmissionsDrug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material.
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December 20, 2018 Medical Devices, Regulatory Affairs, Publishing & SubmissionsEvery year, FDA regulates more than 190,000 medical devices pertaining to different classes. In order to provide better healthcare, the agency is striving continuously to update the pathways through which these devices are being submitted. In a recent press release, FDA announced that the agency is looking at the potential aspects to update the 510(k)-clearance pathway for medical devices.
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October 4, 2018 Regulatory AffairsAny modification to the drug substance manufacturing process such as facility / equipment changes, synthetic route changes etc. has the potential to affect the final drug product’s quality / efficacy / safety.
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November 3, 2017 Regulatory Affairs, Publishing & SubmissionsIn recent years there has been an unprecedented increase in the number of submissions of Abbreviated New Drug Applications (ANDAs) and 505 (b) (2) applications, mainly owing to the spurt in the number of follow-on insulins submitted via the 505 (b) (2) pathway and with a record increase of generic drug applications submitted and...
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September 29, 2017 Medical DevicesThe US Food and Drug Administration (FDA) has announced that it may release finalised guidelines for the device changes that would need a new 510(K) submission before 8th November, 2017.
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September 20, 2016 Consumer Healthcare, Cosmetics Regulatory Services, Regulatory Affairs, Health Authority UpdatesIn a recent announcement, the Food and Drug Administration (FDA) has established that the antiseptic wash products with certain (19 in number) active ingredients can no longer be marketed.