COVID-19 outbreak necessitated an extensive study on the Personal Protective Equipment (PPE) regulations. Depending on the PPEs’ (face masks, gloves and gowns) therapeutic purpose, TGA has designed certain guidelines for manufacturers, consumers and healthcare professionals.
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May 27, 2020 Medical Devices, Regulatory Affairs -
April 23, 2020 Food and Food Supplements, Regulatory AffairsWith the number of ailments and stress levels rising in the current scenario, people are willing to instantly boost their immunity levels. But for most, the regular diet is far from building up the necessary.
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April 13, 2020 Medical Devices, Regulatory AffairsEver since the World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic, the global health authorities and life sciences organizations are quickly responding to the situation to see how they can make meaningful contributions.
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April 7, 2020 Regulatory AffairsWhile the world is tussling with COVID-19 pandemic, there’s an emergency need for its treatments and vaccines. Though, currently, there is no FDA approved therapy or vaccine for COVID-19, the agency has several tools to expedite the review and approval of a COVID-19 biologic treatment or vaccine, after it emerges.
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February 28, 2020 Regulatory Labeling, Regulatory AffairsThe pharmaceutical supply chains are highly complex, with multiple stakeholders like manufacturers, suppliers, technology providers, packaging partners, and retailers obliged to maintain the Regulatory standards for quality, safety, and procedural accuracy throughout the product lifecycle.
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February 27, 2020 Regulatory LabelingIt is evident that the labeling requirements in the European Union (EU) are quite dissimilar, given various region-specific regulations across the 27 member states. Besides this, the emerging European Regulatory landscape demands life sciences manufacturers to be more cautious in implementing and showcasing the safety information.
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January 29, 2020 Food and Food Supplements, Cosmetics Regulatory Services, Medical Devices, PharmaceuticalIt has been observed for long that innovation drives the life sciences industry, and this would continue perpetually. For the betterment of human health, there have been many innovative drugs/devices released into the market.
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December 26, 2019 Medical Devices, Regulatory AffairsTwo years ago, in 2017, the Food and Drug Administration (FDA) identified a tentative list of Class II medical devices to be exempted from premarket notification requirements. The list came with limitations for certain type of devices then. Referring to the same, the FDA on Oct 24, 2019, announced the proposed final list of Class II devices to be exempted from 510(k) requirements.
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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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October 31, 2019 Medical Devices, Regulatory AffairsWith just six months for the EU Medical Devices Regulation (MDR) to come into full implementation, medical device manufacturers need to start and prepare for the significant changes coming up or they may be at a risk of getting their products removed from the EU market.