Recently, Per the revised Manual of Policies and Procedures (MAPP) of the United States Food and Drug Administration (USFDA) has proposed new labeling rules under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act (FD & C Act).
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September 17, 2021 Regulatory Labeling, Regulatory Software & ServicesWhile creating compliant packaging, controlling the labeling flow and its implementation through artwork, supply chain and printing involves several internal and external stakeholders. Following up with all the teams to meet the time-critical mandates and deadlines can be challenging.
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September 1, 2021 Pharmaceuticals, Regulatory LabelingThe global pharmaceutical industry faces a plethora of challenges when it comes to drug labeling. Ever-changing Regulatory requirements, products that are no longer patentable, and market pricing pressures force the industry to aim for the competitive advantage through increased efficiency.
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August 31, 2021 Pharmaceuticals, Regulatory LabelingAs the use of pharmaceuticals can have a substantial impact on a patient's health and well-being, the information on the label must be clear and correct. It is particularly true when it comes to usage directions, expiration dates and component lists. Thus, an audit of pharmaceutical labeling operations is required.
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August 26, 2021 Regulatory LabelingCommunication effectiveness across the marketing platforms is evaluated primarily based on how well the content engages the audience or, in the case of brands, the consumer. In healthcare, the information available on these platforms is diverse.
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July 28, 2021 Chemicals, Regulatory Affairs, Regulatory LabelingOccupational Safety and Health Administration (OSHA), in alignment with the United Nations’ Globally Harmonized System of Classification and Labeling of Chemicals (GHS), has adopted new hazardous chemical labeling requirements as a part of its recent revision of the Hazard Communication Standard, 29 CFR 1910.1200 (HCS).
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July 15, 2021 Chemicals, Regulatory Affairs, Regulatory LabelingMost of us have come across the terms 'Disinfectants' and 'Sanitizers' during COVID-19. Both the products fall under antimicrobial pesticides. While disinfectants and sanitizers are commonly referred as same, the major difference between them is that the disinfectants kill the microbes, bacteria and virus on the surface whereas the sanitizers reduce their numbers.
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July 14, 2021 Chemicals, Regulatory Artwork Services, Regulatory Affairs, Regulatory LabelingThe chemicals industry plays a pivotal role in producing petrochemicals, polymers, basic inorganics, specialities and consumer chemicals in Europe. European Chemicals Agency (ECHA) implements the EU’s chemicals legislation to protect health, safety and the environment.
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June 3, 2021 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory LabelingLabeling and packaging are the two (2) important stages in the product lifecycle. They allow the consumers to know more about the product and understand its appropriate usage. From a manufacturer’s point of view, correct labeling helps in achieving compliance with the Regulatory bodies, defining the quality and providing statutory warnings to consumers.
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May 19, 2021 Pharmaceuticals, Regulatory LabelingThe Therapeutic Goods Administration (TGA) of Australia has published guidance on TGO 91 and 92 on March 23, 2021 in order to assist sponsors and producers of medicines in complying with the Australian latest labeling standards.