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Focus on Regulation

Tag Archives: labeling

FDA proposes new ways for prescription drugs to become available over-the-counter

On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a prescription, drugs that are currently available only by prescription.  The draft guidance would facilitate these prescription (Rx) to Over-The-Counter (OTC) switches by allowing

FDA Is Looking at the Money Trail: Agency Describes Potential Investigator Bias Based in Part on Industry Payments

Last week, the U.S. Food and Drug Administration (FDA) issued a briefing document in advance of a joint advisory committee meeting held on Wednesday, September 14, 2016. See FDA Briefing Document. It was a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee and was held to discuss “Serious Neuropsychiatric Adverse Events with Drugs for Smoking Cessation.” Id. See title of report. Pfizer, the manufacturer of Chantix (varenicline), a product intended to help patients quit smoking, has asked FDA to remove a box warning of potential psychiatric risks to patients, including suicide and suicidal ideation. Pfizer provided data from a post-marketing study of 8,000 subjects at 140 sites around the world that was designed to assess the real-world risk of suicidal behavior associated with the use of smoking cessation drugs to support its request that the boxed warning be removed.

FDA Notifies Applicants of Intent to Require Sweeping Changes to Labeling for IR Opioid Analgesics and Entire Class of Prescription Opioids

FDA has announced its intent to require new class-wide labeling requirements for immediate-release (IR) opioid pain medications including new black and other safety warnings.  The enhanced warnings are intended “to inform prescribers and patients of additional risks related to opioid use.”  FDA, News Release (March 22, 2016) (hereinafter, “News Release”).  FDA further announced its intent

Pacira settlement could have ripple effects on a range of FDA issues far beyond promotional claims

We continue to examine the Pacira case documents and give this settlement in-depth thought across all areas of our FDA regulatory practice. As we hinted in our December 17th post, we believe this case could have significant reach. Most obviously, there are implications for the advertising and promotion of drug products, and undoubtedly, FDA will

Taking Another Step Into Modern Healthcare: FDA Proposes Rule to Require Electronic Distribution of Prescribing Information for Human Prescription Drugs

Last month, the Food and Drug Administration (FDA) published a proposed rule, 79 Fed. Reg. 75506, requiring manufacturers to distribute prescribing information (PI) electronically—in lieu of paper copies—to satisfy the regulatory requirement that a prescription drug bear adequate instructions for use on or within the drug’s package. Traditionally, manufacturers have met this requirement by providing a copy of the PI printed on thin paper in small font, and folded in an origami-like fashion so that the PI can fit in the drug carton or be attached to the drug’s packaging.

Ninth Circuit Suggests Flexibility in Type Size for Food Statements of Identity

While the Ninth Circuit’s recent ruling in POM Wonderful v. Coca-Cola has received attention for its holding on preemption, the decision provides interesting statements in the technical realm of the FDA’s type-size requirements for statements of identity in food labeling. The issue involved the statement of identity for Coca-Cola’s Pomegranate Blueberry Minute Maid drink, “Pomegranate