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FDA
FDA Finalizes Guidance Regarding Complex Products Meetings
Late last year, the United States Food and Drug Administration (FDA) finalized a guidance entitled, “Formal Meetings Between FDA…
FDA Releases Draft Question and Answers Guidance on Interchangeable…
In late 2020, the United States Food and Drug Administration (FDA) issued a draft set of four questions and answers guidance that…
CDRH Releases List of FY 2021 Priority Guidance Documents
Recently, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced a list…
OPDP Director Tom Abrams Retires
In October of this year, Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) Director Tom Abrams…
FDA Announces End of Unapproved Drugs Initiative
On Friday, November 20, 2020, the United States Food and Drug Administration (FDA) announced it would end the Unapproved Drugs…
FDA Proposes Clarifying Intended Use Regulations
Earlier this year, the United States Food and Drug Administration (FDA) published a proposed rule that would amend its “intended…
FDA Draft Guidance on Postmarking Reporting
The FDA issued a draft guidance regarding its postmarketing requirements (PMRs) and commitments. The document details how drug and…
FDA Temporary Guidance Outlines Path for Manufacturing to Return to Normal
A new temporary guidance for drug and biologics manufacturers from the U.S. Food and Drug Administration (FDA) details…
Trump Administration Finalizes Drug Importation Rule
Earlier this year, the Trump Administration released a final rule focused on allowing states and others to establish programs to…
FDA Holds Public Meeting on Communication with Industry
On August 11, 2020, the United States Food and Drug Administration (FDA) held a public meeting to discuss a report that reviewed…