The health authority of Canadian landscape, Health Canada (HC) has revised the submission requirements and mandated submissions to be in electronic format for certain filings post January 1st, 2018.
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December 7, 2017 Publishing & Submissions -
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...
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May 25, 2017 Publishing & Submissions, Health Authority UpdatesWith the FDA concluded its mandatory first phase electronic submissions deadline, first question drug manufacturers could ask themselves is what’s next in line? Where else they can submit their data and which format they should get adopted to? With their target focused on global markets, we suggest to take one-at-a-time approach.
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April 13, 2017 Regulatory Affairs, Publishing & SubmissionsEver since the Hatch-Waxman Act came into being, the generic drugs have saved billions for both patients and healthcare systems alike and accounted for 88% of the prescription drugs sale in the United States alone.
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April 7, 2017 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesEver since the electronic submissions initiated, there are growing instances that both health authorities and drug manufacturers are being benefitted.
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April 4, 2017 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesEven though the eCTD (Electronic Common Technical Document) format has been in existence for nearly ten years, now it has become a focal point for pharmaceutical, biologic and generic drugs manufacturers because of the US FDA (Food & Drug Authority) mandate stating that all NDAs (New Drug Application), BLAs (Biologics License Applications) and ANDAs (Abbreviated New Drug Applications) must...
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March 28, 2017 Medical Devices, Publishing & SubmissionsFor the betterment of healthcare enabling the end user get ultimate benefits of safety and efficacy, there is always a reserved space for invention in the field of medical devices. With the technological development, medical device manufacturers are always on their toes to come up with the best possible innovative products.
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March 21, 2017 Publishing & Submissions, Health Authority UpdatesAhead of nearing mandatory eCTD deadline, 5/5/2017, to clear the confusion surrounded, the Food and Drug Administration (FDA) of United States has clarified what exactly it is looking for in the Type III Drug Master File (DMF) submissions.
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February 28, 2017 Publishing & Submissions, Health Authority UpdatesAs we all are aware, the United States Food and Drug Administration’s (US FDA’s) electronic Common Technical Document (eCTD) requirement is nearing the deadline.
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February 3, 2017 Publishing & Submissions, Health Authority UpdatesWhat does it mean for Drug Approval Processes?