Medicine labels act as a first-hand guide for the users and help to use the products qualitatively. Therefore, it is highly important to that the information available on the labels is consistent, easy-to-read and error-free, and on par with the global standards.
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October 31, 2019 Pharmaceutical, Regulatory Labeling, Regulatory Affairs -
August 30, 2019 Pharmaceutical, Regulatory AffairsAre you a manufacturer of Prescription and Over the Counter (OTC) drugs? Then it is obvious that you are aware of the US Consumer Product Safety Commission (CPSC) regulations under which certain consumer products, including many prescription and OTC drugs are subject to special packaging standards, including Child-Resistant Packaging (CRP) Statements in drug labels.
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July 16, 2019 Pharmaceutical, Regulatory AffairsOver the past few decades, Pharmacovigilance (PV), has been instrumental in detecting, assessing, understanding and preventing adverse events. In the due course, drug manufacturing organizations have implemented safety and PV systems with due diligence to stay compliant with Health Authority (HA) requirements.
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July 12, 2019 Pharmaceutical, Regulatory Affairs, Publishing & SubmissionsIt is well known that, the Food and Drug Administration (FDA) has been working to implement the transition of biological products which are currently approved as drug products and are ‘deemed to be licensed’ as biologics under the Public Health Service Act on March 23, 2020.
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July 10, 2019 Pharmaceutical, Regulatory Affairs, Publishing & SubmissionsDrug 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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March 4, 2019 Artwork Pack Management, Pharmaceutical, Regulatory AffairsThe impact of Brexit is evident in almost every industry based in the European Union (EU) and the United Kingdom (UK). Pharmaceutical industry too not to be spared.
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February 14, 2019 Medical Devices, Pharmaceutical, Regulatory AffairsArtificial Intelligence (AI) is paving the way for innovative medicinal products and advanced medical devices. It is gradually headed towards decreasing repetitions in clinical trials, increasing the accuracy in drug designing processes and disease identification, personalization of patient diagnosis etc.
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January 29, 2019 Pharmaceutical, Regulatory AffairsDid you know, as reported, every year almost 4500 drug products are called off from the US market? In the past few months, it is observed that the number of recalls has been increased drastically.
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January 7, 2019 Food and Food Supplements, Medical Devices, Pharmaceutical, Regulatory AffairsWith each year, Life Sciences industry is transforming in unpredictable ways, of course it is to better the end-user’s safety. The industry is progressing with technological advancements and the health authorities are equally striving to upgrade the existing Regulatory frameworks to align with market requirements.
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January 2, 2019 Pharmaceutical, Regulatory AffairsAre you a biosimilar/biologic product’s developer/manufacturer? Are you waiting for FDA’s latest stand on biosimilars or soon-to-be Biologics? Here it is. For the development of biosimilars and interchangeable biosimilars, on 11 December 2018, FDA released two new draft Q&A guidance documents under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).