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FDA
FDA Releases Draft Guidance on Diversity in Clinical Trials
The United States Food and Drug Administration (FDA) released a draft guidance that recommended more diverse patient cohorts in…
FDA Revises Guidance on Misinformation About Medical Devices and…
The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices…
FDA Issues Draft Guidance on Diversity Action Plans
Recently, the United States Food and Drug Administration (FDA) released a draft guidance, “Diversity Action Plans to Improve…
OPDP Considers Potential Misleading Implications of Television Ads
Recently, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) research team…
Prominently Displaying Methodology of Studies Improves Physician Perception…
A recent research piece published in the Research in Social and Administrative Pharmacy by the Food and Drug Administration (FDA)…
FDA Seeking Comments on Draft Guidance on Biosimilar Drugs and Reference…
The United States Food and Drug Administration (FDA) recently published revised guidance on promotional labeling and advertising…
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…