Are 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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August 30, 2019 Pharmaceutical, Regulatory Affairs -
January 28, 2019 Medical Devices, Regulatory AffairsAlthough digitization and Internet of Things (IoT) have together enhanced the performance of medical devices, they have also made devices prone to cyber vulnerabilities. The malware and spyware invading the devices are growing. The hackers are mining for loopholes in devices and related software that allow them to corrupt the devices to compromise user data by malfunctioning the devices.
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January 22, 2019 Regulatory Affairs, Regulatory Medical WritingWhile researching for an innovative drug/device/cosmetic/food supplement, a huge amount of clinical data is expected to be generated. The conclusions of such data must be clearly reported with an appropriate level of detail to the health authorities (HAs). The information to be reported or documented might be research data, trial descriptions, findings, warnings etc.
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December 24, 2018 Regulatory Intelligence, Regulatory AffairsArtificial Intelligence (AI) is by far the most talked about technological advancement of this decade. Although the idea of AI has been around for years, the processers and computational speed of the previous era were not up to the mark, thus couldn’t support the analysis of huge data as required.
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November 22, 2018 Regulatory Intelligence, Regulatory AffairsAs a big face lift, Health Authorities of China and South Africa have recently revealed their identifications. The China Food and Drug Administration (CFDA), has recently announced the change related to the agency’s official English name, the National Medical Product Administration (NMPA).
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November 15, 2018 Nutraceuticals/Food SupplementsWide range of food products, dietary supplements and other health foods that are consumed to enhance the nutritional value of food are constantly growing, worldwide. All combined can generally be termed as nutraceuticals.
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November 12, 2018 Regulatory LabelingBe it a drug, device, cosmetic or food product, it is essential to convey the product information with respect to its usage, indications, warnings and other crucial aspects that are informative and beneficial to the end-user.
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November 9, 2018 Cosmetics Regulatory ServicesThe Brazilian Association of personal hygiene, perfumery and cosmetics (ABIHPEC) announced a Regulatory revolution for the Brazilian cosmetics industry. The Health Surveillance Agency (ANVISA) has modified resolution RDC 07/2015 to simplify the regulations put on children products. The reformed resolution removes the obligation of registering the product before launching it into the market.
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August 30, 2018 Cosmetics Regulatory ServicesBrazil’s cosmetic market is flourishing, showing no signs of slowdown even in the economic fluctuations. In Brazil, cosmetics in various segments such as organic, skincare, haircare, etc. are gaining popularity among users, and their market extent is increasing day by day.
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August 21, 2018 Medical DevicesOn August 1, 2018, China Food and Drug Administration (CFDA) - the Chinese health authority, has taken a major step towards classification of medical devices to be marketed or currently being marketed in China. The CFDA has officially published and mandated the new Medical Device Classification Catalog.