MVG Insights
In lieu of the COVID-19 outbreak, the FDA has issued 3 clinical guidances outlining new protocols related to the following: REMS requirements, alcohol-based sanitizer production, and the conduct of clinical trials of medical products. Each guidance resulted directly from the need for current protocol adaptation to address unmet needs due to COVID-19.
1. REMS Requirements
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals. (https://www.fda.gov/media/136317/download)
This protocol addresses drugs subject to REMS with elements to assure safe use (ETASU), which often require laboratory testing or imaging studies. In these cases, the FDA highlights the difficulties of preceding with such processes giving the restrictions resulting from COVID-19. To mitigate unnecessary risk, the FDA is pausing enforcement of these REMS requirements to ensure that instances where testing or imaging is deemed unsafe are avoided.
2. Alcohol-Based Sanitizer
Temporary Policy for Preparation of Certain Alcohol-Based Sanitizer Products During the Public Health Emergency (COVID-19) (https://www.fda.gov/media/136289/download)
In reaction to the shortages of alcohol-based hand sanitizers caused by COVID-19, the FDA is loosening its restrictions on the production of such products by non-regulated entities. Firms will be allowed to prepare alcohol-based sanitizers without fear of FDA repercussions so long as they follow 8 clearly-outlined parameters, which focus on the type/s of alcohol used, percentages of components used, safe packaging, clear labeling and registered distribution.
3. Conduct of Clinical Trails
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (https://www.fda.gov/media/136238/download)
The impact of COVID-19 has had, and continues to have, far-reaching effects, and clinical trials are feeling those ramifications. The FDA recognizes that limitations caused by COVID-19 extend to many aspects of life including travel capability, site access, quarantine measures etc., and as it pertains to the conducting of clinical trials, the priority is to ensure both patient safety and study data integrity. However, it is understood that protocol deviations will be inevitable in many cases and protocol amendments will be widely necessary. The FDA outlines these challenges, specifying best practices, while also addressing common questions.
It is clear that amidst the COVID-19 outbreak, the FDA is taking steps to increase the flexibility of their policies to assist in the effort to mitigate the effects of the virus. MVG mirrors this adaptive methodology and will work closely with clients to aid in their evolving needs during this crisis.
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Sincerely,
Maryanne
Maryanne Visconti Gottfried
President
MVG Consulting Services specializes in helping small to medium sized biotechnology and pharmaceutical companies with their clinical development programs and we can provide start-up and virtual companies with the necessary resources to begin their clinical development program.
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