In March 2020, FDA released a new guidance regarding the enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic. Recognizing that the COVID-19 pandemic is likely to reduce a firm’s capacity to comply with adverse event reporting requirements, this guidance was provided to help firms strategize the use of…
The role of the regulator cannot be overstated. Regulation has been a fundamental aspect of the medico-industrial complex since the Pure Food and Drugs Act was passed in 1906 and the Food and Drug Administration (FDA) was established in the 1930s. Recently, the United States Dietary Supplement Health and Education Act (DSHEA) propelled the regulatory…
Being the “Responsible Person” (RP) is a big responsibility ( no pun intended). Whomever takes on that position needs to take it very seriously, because that person is responsible for interacting with and reporting to FDA adverse events (AE) and serious adverse events (SAE). This is not a “check box” type position, to be performed by anyone…
The narrative section of the MedWatch 3500A form is the heart of the SAE report, and should contain all important information about the case, presented in a reader-friendly fashion. The narrative is likely the first part of the MedWatch read by the medical reviewer (and possibly the only part!), and should be concise, well-written, and…
The assessment of causality – whether the supplement caused the adverse event (AE) – is a very important part of the safety assessment. Although the lawyers out there would argue that it’s very difficult (if not impossible) to prove that a supplement caused an event, there are some factors strongly in favor of causality.…