Tag: FDCA
FDA Announces Critical Off-Label Forum for Drugs and Devices
A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders regarding communications by industry related to unapproved uses of FDA-regulated drugs, biological […]
FDA Releases Five New Compounding Pharmacy Policy Documents
Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s website. Tuesday’s issuances were part of the FDA’s continued implementation of the Drug Quality and Security Act (DQSA), […]
FDA Enforcement of Pharmaceutical Websites Continues
The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently posted an untitled letter to Institut Biochimique SA (IBSA) and Akrimax Pharmaceuticals, LLC (Akrimax), the U.S. agent for Tirosint. The OPDP raised concerns regarding IBSA’s Facebook page for Tirosint because it failed to provide any risk information regarding its use, even though Tirosint is […]
FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines
In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”). This revises the FDA’s 2009 draft guidance document on the subject, which was […]
Johnson & Johnson Finalizes $2.2 Billion Government Settlement
Earlier this week, the U.S. Department of Justice (DOJ) announced that it reached a settlement with Johnson & Johnson (J&J) and two of its subsidiaries — Janssen Pharmaceuticals and Scios Inc. — to resolve civil and criminal health care fraud allegations. The settlement in principle was first announced by J&J […]
Regulator Panel at FDLI’s Advertising & Promotion Conference
The Food and Drug Law Institute (FDLI) is hosting its annual Advertising & Promotion Conference for the Pharmaceutical, Medical Device, Biologic & Veterinary Medicine Industries this week in Washington DC. The conference kicked off this morning with the highly anticipated Food and Drug Administration (FDA) regulator panel that included Thomas […]
Wyeth’s $491 Million Fraud Settlement
The U.S. Department of Justice (DOJ) announced on July 30, 2013 that it had reached a settlement with Wyeth Pharmaceuticals to resolve criminal and civil liability related to the unlawful marketing of its prescription drug Rapamune for uses not approved by the U.S. Food and Drug Administration (FDA) that caused false claims to be submitted […]
