On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to temporarily remain in effect,...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.
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9/29/2020
/ CDRH ,
Centers for Disease Control and Prevention (CDC) ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Intended Use ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Reform ,
Trump Administration ,
Virus Testing
On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical...more
FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall guideline at 21 CFR Part 7. ...more
The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from pharmaceutical manufacturers, although the expected final rule is less...more