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FDA
FDA Proposes New Right to Try Requirements Including Annual Reports from…
In a recently proposed rule, the FDA proposed Right to Try law requirements. The agency will require drug manufacturers to issue…
FDA Abandons DRD Proposal
Earlier this year, the United States Food and Drug Administration (FDA) announced it would no longer pursue a proposed regulatory…
Indivior Agrees to FTC Settlement Over Suboxone Claims
Recently, Indivior, Inc. agreed to pay $10 million to settle allegations by Federal Trade Commission (FTC) that it violated…
Hahn Announces Some FDA Changes to Be Made Permanent
The United States Food and Drug Administration (FDA) made several changes in response to the COVID-19 pandemic, and now 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…