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FDA
FDA Leaders Illuminate Regulatory Path Forward at Dermatology Meeting in…
By Rick Daigle
\FDA Leaders Illuminate Regulatory Path Forward at Dermatology Meeting in San Diego
At the bustling American…
FDA Issues Final Rule, Confirming IVDs are Devices Under the FD&C Act
The United States Food and Drug Administration (FDA) recently published a final rule, making it explicit that in vitro diagnostic…
FDA Will Hold Listening Session on Future of Advisory Committees
The United States Food and Drug Administration (FDA) recently announced a planned listening session on June 13, 2024, as part of…
Senators Urge FDA to Crack Down on Social Media Prescription Drug Promotion
Recently, a bipartisan set of Senators – Senator Dick Durbin and Senator Mike Braun – sent a letter to United States Food and Drug…
FDA Issues Guidance Documents on Direct-to-Consumer Advertisements
To increase transparency and consumer awareness, the Food and Drug Administration (FDA) issued a final rule to amend its…
FDA Authorizes Florida Preliminary Clearance to Import Drugs from Canada
For the first time, the Food and Drug Administration has authorized a state to import prescription drugs from Canada, granting…
FDA Issues Guidance Documents to Streamline Premarket Review and Approval…
The United States Food and Drug Administration (FDA) recently issued two guidances as part of its Drug Competition Action Plan…
Vanda Lawsuit Against United States for Uncompensated Taking Allowed to…
The United States Court of Federal Claims in Washington, D.C. recently denied the United States’ motion to dismiss Vanda…
Former Medical Device Manufacturing Employee Sentenced to Prison for…
A former employee of a medical device manufacturing company was recently sentenced to 12 months in prison and one year of…
FDA Issues First Untitled Letter of 2024
The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently issued the first…