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FDA
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…
FDA Releases Finalized Guidance on Use of Real-World Data in New Drug and…
Recently, the United States Food and Drug Administration (FDA) finalized two guidance documents that outline how sponsors can use…
New Report Outlines a Roadmap for Restoring Public Trust in the FDA
The Hastings Center recently released a report with a roadmap on how the United States Food and Drug Administration (FDA) can…
FDA Announces Small Entity Compliance Guide on DTC Radio and Television…
On December 27, 2023, the United States Food and Drug Administration (FDA) announced a new small entity compliance guide (SECG),…
FDA Releases Final Rule for Direct-to-Consumer Prescription Drug…
Recently, the United States Food and Drug Administration (FDA) released the final rule for Direct-to-Consumer Prescription Drug…