Drug development is no cakewalk. Pharmaceutical companies are obliged to prove drug safety and efficacy to Regulatory authorities at every single stage of drug development. Based on the authority’s approval or disapproval only, the companies can further go into later stages of drug development and/or can relook into the entire developmental process.
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July 10, 2019 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions -
June 25, 2019 Medical Devices, Compliance, Audit and Validation, Publishing & SubmissionsIn December 2018, the United States Food and Drug Administration (US FDA) published the final guidance on Manufacturing Site Change Supplements: Content and Submission. Replacing the 2015 draft guidance, the final guidance clarifies the responsibilities of medical device manufacturers who are willing to change their manufacturing site for an approved device.
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June 3, 2019 Regulatory Affairs, Publishing & SubmissionsBiological medicinal products have become the promising solutions in the prevention and treatment of several life-threatening, chronic diseases and health conditions. Realizing this scope, several pharmaceutical companies are venturing into producing biological products like never before.
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April 8, 2019 Regulatory Affairs, Publishing & SubmissionsHealth Canada (HC) announced the revision of the validation rules for Regulatory transactions in electronic Common Technical Document (eCTD) format and published them as Version 4.4 on March 6, 2019.
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March 25, 2019 Regulatory Affairs, Publishing & SubmissionsFor the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for Type III Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format.
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February 18, 2019 Publishing & SubmissionsThe impact of Brexit has been a major topic for debates amongst the industry experts for the past two years. It has left companies on both the sides, the United Kingdom (UK) and Europe, hanging on a loose thread. As the date of Brexit is drawing closer, industries are aggressively looking for contingency plans for sustaining their business, if the UK leaves with a ‘no-deal’.
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December 27, 2018 Regulatory Artwork Services, Food and Food Supplements, Compliance, Audit and Validation, Consumer Healthcare, Cosmetics Regulatory Services, Medical Devices, Pharmaceuticals, Registration Strategy, Regulatory Intelligence, Regulatory Labeling, Regulatory Software & Services, Regulatory Affairs, Market Access, Regulatory Consulting, Publishing & Submissions, Regulatory Medical Writing, Health Authority UpdatesThe life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
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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 1, 2018 Regulatory Affairs, Publishing & SubmissionsIs it a right time to enhance the submission format for efficiency and consistency of Regulatory quality assessment? The outcome of recent discussions between USFDA (US Food and Drugs Administration) and the Pharmaceutical Science and Clinical Pharmacology Advisory suggests a positive sign.
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June 19, 2018 Publishing & SubmissionsAre you currently planning an eCTD (electronic common technical documents) submission to Australia? If you are intended to, then take a pause and look out for the changes which are to be done while preparing your dossier for the region.