Keeping you updated on the latest Medicare and Part D news

FDA Plans to Strengthen Regulatory Presence

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Following the ban of the fourth Ranbaxy Laboratories facility and growing concerns about the safety of imported drugs, the FDA announced yesterday that it will strengthen its regulatory presence in India. FDA Commissioner Margaret Hamburg conducted an 8-day visit of India, meeting with various drug companies and affiliated groups to discuss manufacturing quality. 

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Furthermore, the FDA released plans to establish an Office of Pharmaceutical Quality to improve oversight of brand, generic, and OTC drugs. The FDA is currently working with the pharmaceutical industry to determine quality indicators and create data collection processes. Also, Congress has a briefing scheduled for February 26th on the subject of substandard generic drug imports.

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