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FDA
FDA Responds to Clinical Trials & Part 11 Compliance During COVID-19
The U.S. Food and Drug Administration (FDA) issued updated guidance on how to conduct clinical trials during the COVID-19 public…
FDA Issues Guidance on Formal Meetings and User Fees Applications During…
Recently, the US Food and Drug Administration (“FDA”) issued a guidance regarding the effects of the COVID-19 crisis on formal…
Will COVID-19 Impact Drug Approval Timelines?
With the COVID-19 pandemic hitting countries around the world hard, the United States Food and Drug Administration (FDA) has its…
FDA and FTC Taking Quick Action Against COVID Scammers
Since the declaration of a public health emergency related to COVID-19 in February 2020, there has been an overwhelming response…
FDA User-Fee Reviews Continue through COVID-19
While many facets of our lives have been put on hold due to COVID-19, the United States Food and Drug Administration (FDA) has…
FDA CDRH Issues Guidance on Notifications of Medical Device Shortages
Recently, the US Food and Drug Administration (“FDA”) Center for Devices and Radiological Health (“CDRH”) published guidance…
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…