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FDA
FDA Issues Revised Guidance on Adverse Event Reporting During a Pandemic
In response to rapidly changing conditions due to the COVID-19 pandemic, the US Food and Drug Administration (“FDA”) published a…
FDA Publishes Final Guidance on Competitive Generic Therapies
The US Food and Drug Administration (“FDA”) recently issued a final guidance on the Competitive Generic Therapies (“CGT”) program.…
FDA COVID-19 Special Emergency Program for Accelerating Research and…
Recently, the Food and Drug Administration (FDA) detailed a new “special emergency program” for accelerating research and…
FDA Issues Guidance on Drug Shortage Notifications
In view of potential drug supply interruptions due to the COVID-19 pandemic, the US Food and Drug Administration (“FDA”) recently…
Understanding FDA Regulatory Terminology During COVID-19
To update clinicians on the various terminology used by the FDA on treatments related to COVID-19 we have developed this reference…
FDA Eases Some Requirements in the COVID-19 Fight
Recently, the United States Food and Drug Administration (FDA) eased some requirements to allow for more access to masks, personal…
DOJ, FDA and HHS Sound the Alarm About COVID-19 Fraud Schemes
Apparently, scammers are hard at work trying to exploit the COVID-19 pandemic. In the last couple of weeks, multiple agencies…
FDA Halts United States Inspections
On March 18, 2020, the United States Food and Drug Administration (FDA) announced that it was suspending routine surveillance…
OPDP Issues Warning Letter to Outlook Pharma Over Sponsored Link
On February 21, 2020, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a Warning…
FDA Guidance on Coronavirus Testing
Recently, the U.S. Food and Drug Administration (FDA) released a guidance that accelerated the ability for certain laboratories to…