Face shields have gained utmost significance as the primary protective equipment to curb the spread of the COVID-19. Considered as a Personal Protective Equipment (PPE), face shield is made up of a transparent window or visor, that protects the face and associated mucous membranes (eyes, nose and mouth) against the potential exposure to infectious diseases.
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October 22, 2020 Medical Devices -
October 22, 2020 Medical Devices, Regulatory AffairsMultiple function device products are medical products that have at least one device function (medical) and one non-device function (non-medical) or other function. Among these, some are subjected to FDA’s Regulatory oversight as medical devices, while others are not.
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October 13, 2020 Medical DevicesSince the commencement of Brexit transition timelines, the entire medical devices community is underway to understand its impact on future trade and Regulatory relations between the European Union (EU) and the United Kingdom (UK). As noted, the UK left the EU on January 31, 2020, as per the Withdrawal Agreement between both the countries.
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October 13, 2020 Medical Devices, Regulatory AffairsCouple of months back we thoroughly discussed about FDA’s expedited Regulatory pathways during medical emergencies.
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October 13, 2020 Medical DevicesThe Mexican Regulatory Authority, COFEPRIS (The Federal Commission for Protection against Sanitary Risk) has established a new electronic appointment system for medical device registrants for submitting applications or seeking in-person meetings with the Agency.
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October 12, 2020 Food and Food Supplements, Regulatory Labeling, Regulatory AffairsOn August 12, 2020, the United States Food and Drug Administration (USFDA) released a final rule for the labeling of food products falling under the category of fermented and hydrolyzed food.
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October 8, 2020 Pharmaceutical, Regulatory AffairsIt is a known fact that the UK has officially left the European Union (EU) on January 31, 2020 and it is in the transition period until December 31, 2020. During the transition period, all the pharmaceutical companies in the UK must abide by the EU pharmaceutical law.
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October 6, 2020 Compliance, Audit and Validation, Pharmaceutical, Regulatory Intelligence, Regulatory AffairsAs we all aware, COVID-19 pandemic resulted in the suspension of regular on-site inspections and as the world is slowly coming out of COVID-19 restrictions, Health Agencies are eying on resuming the on-site inspections.
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October 6, 2020 Pharmaceutical, Regulatory AffairsSince the discovery of nitrosamine impurities as human carcinogens in mid-2018, FDA has been investigating and conducting a detailed analysis of the impurities in human drugs and APIs.
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Health Based Exposure Limits (HBELs) - Regulatory Expectations and Challenges An Informative Webinar
October 5, 2020 PharmaceuticalPharmaceutical companies sometimes manufacture the products using multipurpose manufacturing facilities to develop different medicinal products. Production at such facilities may create potential cross-contamination and pose a risk on products’ safety and efficacy.