Re: Australian Regulator Investigates Google Data
Bok Mull
Increased numbers of patients with chronic conditions use nutraceuticals or food-based therapeutics. However, to date, there is no global consensus on the regulatory processes for nutraceuticals. With the increased use, issues of quality and safety have also arisen. This review summarises the current regulations held for nutraceuticals in the USA, European and Australian jurisdictions using regulatory authority sites and databases. The efficacy and safety concerns, product development, gaps in regulation and challenges in ensuring product authenticity are also summarised. The data highlight the complexity that the globalisation of nutraceuticals brings with respect to challenges in regulation and associated claims regarding efficacy and safety. The development of an effective system with integrity is needed to increase vertical collaboration between consumers, healthcare practitioners, and government agencies and the development of international risk assessment criteria and botanical compendia. This will help in greater transparency and improved trust in the process and products. Emerging technologies could play a role in improving systems engineering by information sharing and leveraging the strengths of different countries. In conclusion, nutraceuticals have been poorly regulated leading to spurious claims based on little or no real evidence. This makes it difficult to separate meaningful results from poor data. More stringent regulation and an effective system of integrity are required to ensure efficacy and safety and enable the adequate monitoring and increase consumer and healthcare professionals' confidence.
The DSHEA aims to distinguish between food and drugs regulatory frameworks and became the fundamental body that governs the regulation of dietary supplements in the USA. Based on this act, manufacturers are responsible for the efficacy, safety, and quality assurance of their products by illustrating the explicit ingredients used in the product and any potential allergies [13]. The acts aim to establish a clear and uniform definition of the term dietary supplement and outline the beneficial qualities of using dietary supplements and enable the FDA to assert jurisdiction over the establishment of Good Manufacturing Practices (GMPs) that are specific to the dietary supplement industry. The DSHEA promotes scientific studies of dietary supplements and encourages research funding to investigate the health benefits of dietary supplements. Clinical trial data and toxicological data are required for various scenarios based on whether the anticipated exposure to the substance exceeds historical consumption. As a result, the Office of Dietary Supplement Regulation was established within the National Institutes of Health to ensure that the survey requirements set by the DSHEA are met [14]. However, the Office of Dietary Supplement Regulation does not play a role in implementing the regulations outlined by the DSHEA.
Britain's data privacy regulator said Thursday it was investigating 30 organisations including Facebook over their use of personal data and analytics in political campaigning. googletag.cmd.push(function() googletag.display('div-gpt-ad-1449240174198-2'); ); The announcement came after Facebook admitted the personal data of up to 87 million users, mainly in the United States, was improperly shared with UK political consultancy Cambridge Analytica.Information Commissioner Elizabeth Denham said in a statement she was "investigating 30 organisations, including Facebook"."The ICO is looking at how data was collected from a third party app on Facebook and shared with Cambridge Analytica."We are also conducting a broader investigation into how social media platforms were used in political campaigning," she said.Denham said Facebook had been co-operating with the investigation and she was "pleased" with changes they have made.But she added that "it is too early to say whether they are sufficient under the law," warning that the investigation "could result in enforcement action" and "policy recommendations".Facebook has been scrambling for weeks in the face of the disclosures on hijacking of private data by the consulting group working for Donald Trump's 2016 campaign.The British firm responded to the Facebook announcement by repeating its claim that it did not use data from the social network in the 2016 election. 2018 AFP
We present data from 72 interviews with regulators and industry representatives regarding their trust in and communication with one another. Interviews were conducted in the UK, New Zealand, and Australia in 2013.
For the purposes of this paper, the use of the term regulator is inclusive of both individuals responsible for developing food safety standards and for enforcing food safety standards. The term industry is inclusive of a variety of individuals and organisation types (e.g., grocers, small business owners, and large corporations). Our analysis of these perspectives has allowed us to identify barriers and facilitators to communication and trust, and potential areas of conflict that are problematic from a public health perspective that may be amenable to change. A variety of data-driven solutions are provided for (re)building trusting and communicative relationships between the two parties, with the end goal of protecting the public.
Consumers in industrialised countries increasingly demand foods that are safe and of high quality. This, alongside the interest of public health and an increasingly globalized food system, has led to the development of food safety standards [26]. This paper presents the views of individuals in food regulation (the regulators), and those in the food industry (the regulated), regarding their trust in and communication with one another within three countries: the UK, New Zealand, and Australia. Our primary aim was to provide recommendations, from representatives of industry and regulation, for facilitating the (re)building of trusting and communicative relationships between the two parties, with the end goal of increasing compliance with regulation and protecting public health. As an outsider, food safety standards may be viewed as a set of rules or best practices, enforced by one or more regulatory body. We may view industry then as compliant, or noncompliant. However, as we have shown, there are a variety of factors that shape the dynamic and complex relationships between regulators and industry, and the nature or extent of partial or (non)compliance. It is by speaking with these actors that we can identify barriers to compliance that are amenable to change. The following outlines key barriers and points of conflict identified in the data, with the primary aim being to propose solutions relevant to improving regulator-industry communication and trust. In doing so, we identify that while trust needs to occur at an interpersonal level between individual actors, trust at an institutional level also needs to occur. At times, participant comments were suggestive of a boarder distrust in either the systems of regulation or industry in general.
Europe's national privacy regulators said on Thursday that the decision came following discussions about recent enforcement action undertaken by the Italian data protection authority against OpenAI regarding its ChatGPT service.
Pay particular attention to notice periods, which depend on the laws and regulations you need to comply with and the type of data affected (personal data, financial data, etc.). Failure to notify regulators in a timely manner could result in liability and extensive fines:
Regulators rigorously evaluate scientific and clinical evidence provided by vaccine manufacturers. Vaccine manufactures are legally obliged to follow defined standards in the data they provide, and their clinical research and manufacturing operations are subject to regulatory oversight. Either full or summary data from clinical trials is made available to regulators as part of vaccine evaluation. Each vaccine is thoroughly assessed for safety, efficacy and quality to determine whether it can be approved for use. Regulators use available scientific evidence from preclinical laboratory research, human clinical trials, and manufacturing information to assess benefits and risks of candidate vaccines. Regulators have collaborated extensively with other global regulatory counterparts in premarket and safety reviews.
All adverse events need to be examined and reported in the regulatory submission by the companies for a marketing authorisation. Typically, regulators will require that participants in clinical trials have been followed for generally at least 2 months after receiving their final vaccine dose for decisions made under emergency or provisional or conditional approval processes, with longer follow up required before full market authorisation is granted. One year or longer safety data are now available for many of the most widely used vaccines. While rare adverse events might not be recognised until after wide population use, based on both the current experience with COVID-19 vaccines and previous experience with other vaccines, most adverse events occur days to a few weeks of vaccination and will be identified in clinical trials. There will also be longer term (for example 1 to 2 years) follow up of those who participated in the clinical trials of each vaccine, which is standard practice in clinical trials, as well as population wide observational safety studies. Safety data from these longer-term trials and population studies are being carefully reviewed by regulators as part of post approval monitoring of safety. International regulators collaborate on the review of safety allowing an increase in the size of the populations for which safety data can be assessed.
Apart from information on the types of immune responses induced by the vaccine, companies must submit data from well-designed clinical trials to regulators to demonstrate that the vaccine prevents COVID-19. The data showed there were sufficient numbers of people included in the clinical trials receiving the vaccine so that the efficacy of the vaccine can be accurately measured (generally at least 10,000 and usually 15,000 or more people who receive the vaccine, in addition to those in the control arm). Populations in clinical trials should include a range of age groups and people with co-morbidities. Given the disproportionate impact of COVID-19 on older people, COVID-19 vaccine clinical trials have included significant numbers of older participants.
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