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FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19

The U.S. Food and Drug Administration continues to play a critical role in accelerating medical countermeasures to treat and prevent COVID-19. As part of the response to this pandemic, the agency is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood.

Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic

As part of the U.S. Food and Drug Administration's ongoing commitment to fight the Coronavirus Disease 2019 (COVID-19) pandemic, today the agency issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components. 

Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19

As part of the Trump Administration's all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency's disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.

COVID-19 FDA Update: Daily Roundup

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic. Read on.

FDA Expedites Review of Diagnostic Tests to Combat COVID-19

The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S.

Coronavirus (COVID-19) Update: Daily Roundup

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic.

Insulin Gains New Pathway to Increased Competition

The U.S. Food and Drug Administration reports today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway.

Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic.