February FDA Updates
February FDA Updates
As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and produ
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FDA Working to Address 2019 Novel Coronavirus (COVID-19): Diagnosis & Treatment (Part III)
... ›FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including
FDA Working to Address 2019 Novel Coronavirus (COVID-19): Supply Chain (Part II)
... ›FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including
FDA Working to Address 2019 Novel Coronavirus (COVID-19): Product Safety (Part I)
... ›FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including
January FDA Updates
... ›As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and produ
FDA and Real-World Evidence in 2019
By: Keunbong (KB) Do
... ›Around the end of 2018, FDA published the “Framework for FDA’s Real-World Evidence Program” (the “Framework”).[1] The Framework is to provide a basis for the ag
Digital Health in 2019
... ›The year 2019 saw relatively few developments in the digital health space. Although progress has been slow, FDA did make headway on two initiatives: (1) address
2020 Under Dr. Stephen Hahn, FDA’s New Commissioner
By: Julie Y. Park
... ›Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17
- - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 3)
... ›Our earlier posts (part 1 and part 2) looked at a few overall trends at FDA as well as the impact of consent decrees issued in 2019. Today we will highlight som
- - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 2)
... ›Yesterday, we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our