Time To Make Your Brand Awesome!
This is an unprecedented time in world history. Never in our modern time, has the globe been in such position and although there isn't much we can do, we can certainly hope for the best, pray, abide by the quarantine and take care of ourselves and our loved ones. it's important that we also take this time to improve ourselves and our affairs. That time is NOW.
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 their resources and the FDA prioritize their focus to reports related to medical products indicated for the treatment or prevention of the pathogen causing COVID-19.
Please note that although this guidance may relax some of the required timeframes for adverse event reporting, the FDA still encourages all firms to plan to maintain the highest possible level of adverse event monitoring and reporting throughout the pandemic period. All adverse event data should be handled via the usual standard operating procedures, and regulatory and statutory requirements for adverse event reporting should be met to the maximum extent possible.
We’re here to help!
Let Supplement Safety Solutions be your regulatory partner during these uncertain times. We can help you maintain the highest level of adverse event monitoring and reporting while you navigate the impact of the COVID-19 pandemic on your business operations. We’ll review all Adverse Events associated with the use of your supplement and assess and document every reported Adverse Event. When the pandemic is resolved, we’ll serve as your Responsible Person to the FDA, reporting all Serious Adverse Events on MedWatch Form 3500A or the Safety Reporting Portal (SRP) and interacting with the FDA on your behalf.
Please private message me to schedule your free consultation.
Best to you,
James Villepigue CSCS