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FDA
OPDP Sends Untitled Letter to Merz Over Social Media Post
The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently sent an Untitled Letter…
Stakeholders Provide Feedback on FDA Misinformation Draft Guidance
Earlier this year, the United States Food and Drug Administration (FDA) issued a draft guidance, “Addressing Misinformation About…
FDA Issues Reports on Communication and Guidance Document Best Practices
The US Food and Drug Administration (FDA) has published reports on communications and guidance documents as mandated by Congress…
Updates from FDA’s Office of Prescription Drug Promotion: Standards…
In a recent presentation at the 25th Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, Catherine Gray, the…
FDA Releases Draft Guidance on Randomized Controlled Drug Trials in Routine…
Recently, the United States Food and Drug Administration (FDA) issued a draft guidance, Integrating Randomized Controlled Trials…
OPDP Sends Untitled Letter to Kaleo for Influencer Social Media Post
The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent an Untitled Letter to…
Mirati Therapeutics Receives Untitled Letter from OPDP for Overstating…
The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently sent an untitled letter…
OPDP Sends Untitled Letter to AbbVie Over Ubrelvy Television Ad
The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently sent an Untitled Letter…
FDA Releases Draft Guidance on Diversity in Clinical Trials
The United States Food and Drug Administration (FDA) released a draft guidance that recommended more diverse patient cohorts in…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The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices…