FDA Divulges Guidance for Conducting Clinical Studies During COVID-19 Pandemic

 FDA Divulges Guidance for Conducting Clinical Studies During COVID-19 Pandemic

FDA Divulges Guidance for Conducting Clinical Studies During COVID-19 Pandemic

Shots:

  • The US FDA has issued guidance to aid sponsors & IRBs for assuring the safety of participants in clinical studies, maintaining compliance with GCP and to reduce the risk to trial integrity during the COVID-19 pandemic
  • FDA recommended alternative methods for assessments i.e. contacting patients by phone or virtual visits and offering additional safety monitoring for candidates who may not have access to the investigational therapy or trial site
  • The FDA plans to keep clinical research going and is offering a level of flexibility to work with sponsors to manage how clinical studies may be impacted by changing conditions

Source 1, Source 2 ­to­ read full press release/ article | Ref: FDA, FDA | Image: FDA

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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