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There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceuticalcompanies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.
Pharmaceuticalcompanies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. However, RSV has proven to be fully capable of undergoing mutations and viral escape when challenged with pharmaceuticals.
Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.
The agency had never said that this was not a permitted practice and only made it clear by issuing the letters, rather than having enunciated the parameter through a guidance document about digital communications. FDA said they would produce a guidance by the end of 2010, but did not. One of them was about the appropriate use of links.
Source: Deloitte Combining these types of health data allows pharmaceuticalcompanies to understand a person’s health and genetic profile better, thereby improving the quality of healthcare products and services. Pharma companies deal with enormous amounts of health data. What Is Health Data Management?
2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.
Of the world’s 20 largest pharmaceuticalcompanies, 17 have launched programmes tailored towards increasing medication access in low- and middle-income countries – up from just eight in 2010. Figure 1: Social media posts from pharmaceutical firms mentioning “environment”. A similar theme is evident in company filings.
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