Category Archives: FDA

Compliance Congress: Walking the Line

Pharma industry executives, FDA officials and Department of Justice attorneys speaking last week at CBI’s 11th annual Pharmaceutical Compliance Congress (PCC) offered solutions and threats to companies hoping to avoid enforcement actions.
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FDA Guidances, OIG Investigations to Shape Drug Marketing, Research

Marketers may see further advice from the Food and Drug Administration in the coming year that clarifies how they can use social media. Priority topics:  presenting risk and benefit information in limited space; correcting independent/third party misinformation about a drug or medical device; and appropriate use of links, according to the agenda for the Center […]
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Waxman Retirement, Tip of the Iceberg

The Washington health policy world is headed for a major shake-up next year, as more long-time leading legislators opt for retirement. The recent announcement that Rep. Henry Waxman (D-Calif) will leave marks the end of a 40-year career on Capitol Hill, highlighted by engineering enactment of legislation that established the generic drug industry, supported treatment […]
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FDA Extends Oversight of Large Compounders

Moving fast to bolster its authority over compounding pharmacies that operate as manufacturers of prescription drugs, FDA is urging “outsourcers” to register, seeking state support, and moving to issue more rules and guidance. The agency is pleased that 14 outsourcers registered through mid-January. The number is small, considering that an estimated 3000 compounding pharmacies make […]
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FDA Prohibits Another Ranbaxy Facility from Producing Drugs for US Market

FDA has reported that it notified Ranbaxy Laboratories, Ltd., on Jan. 23 that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January […]
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