Every 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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December 20, 2018 Medical Devices, Regulatory Affairs, Publishing & Submissions -
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.
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Ever evolving Regulatory landscape, healthcare system reforms, and on-going technological advancements: with these factors influencing regulatory procedures at the most, the biggest task for life sciences organizations is to reduce the operational costs while managing the procedural efficiency for end-to-end compliance.
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Identify the best suited software ahead of time
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Japan has a unique set of processes and agencies for the regulation of drugs. The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are the two main Regulatory Agencies that oversee the approvals of the drugs as per the regulatory prerequisites in Japan.
Investigational New Drug (IND) Filing Process
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Regulatory functions such as submission and publishing, regulatory intelligence, labeling, etc. are intricate areas of the regulatory spectrum that are ever evolving. There is no doubt to the fact that some real time challenges are involved in submission processes especially now when the world is shifting from paper to electronic submissions.
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March 22, 2016 Regulatory Affairs, Regulatory Medical WritingIn the first part of this series, we discussed what actually a medical writer does. In this segment, we will talk in detail about the process of medical writing.