FDA issues COVID-19 policies on clinical trials for medical products, mammography quality standards.

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FDA issues COVID-19 policies on clinical trials for medical products, mammography quality standards.
tjordan_drupal
Dec 7, 2020

The Food and Drug Administration Dec. 4 issued guidance on how to conduct clinical trials for medical products during the COVID-19 public health emergency. FDA said the guidance provides general considerations to assist trial sponsors in assuring participants’ safety, maintaining compliance with good clinical practices and minimizing risks to trial integrity.

The agency also on Dec. 4 issued an enforcement policy for mammography quality standards during COVID-19. The enforcement policy provides general considerations to facilities that, because of COVID-19, may have temporarily ceased performing mammography or that may be continuing to perform mammography while facing difficulty in complying with certain quality standards requirements during the public health emergency.

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FDA issues COVID-19 policies on clinical trials for medical products, mammography quality standards.
tjordan_drupal
Dec 7, 2020

The Food and Drug Administration Dec. 4 issued guidance on how to conduct clinical trials for medical products during the COVID-19 public health emergency. FDA said the guidance provides general considerations to assist trial sponsors in assuring participants’ safety, maintaining compliance with good clinical practices and minimizing risks to trial integrity.

The agency also on Dec. 4 issued an enforcement policy for mammography quality standards during COVID-19. The enforcement policy provides general considerations to facilities that, because of COVID-19, may have temporarily ceased performing mammography or that may be continuing to perform mammography while facing difficulty in complying with certain quality standards requirements during the public health emergency.

COVID-19: CDC, FDA and CMS Guidance

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