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Center for Drug Evaluation &
Research (CDER) News

• Drugs@FDA Downloadable Data Files (updated)
• Drugs Shortages: Current Drug Shortages; Cisplatin Injection 1mg/ml
• ETHEX and FDA notify heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets. MedWatch Safety Information

December 23, 2008

• DDMAC Letter: HUMIRA (adalimumab) Injection, Abbott
• Drug Approval Reports (updated)

December 22, 2008

• Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
• FDA warns consumers about tainted weight loss pills. FDA News
• Office of Generic Drugs: List of Authorized Generic Drugs (updated)

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December 24, 2008
	Class I Medical Device Recall: Stryker Leibinger USA., Stryker Custom Cranial Implant Kits
December 23, 2008
	Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300; Availability
December 22, 2008
	Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly Emergency Medical Device Shortages Program Survey)
	Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
	Circulatory System Devices Panel Advisory Meeting, November 20, 2008 - Transcript
	General and Plastic Surgery Devices Panel Advisory Meeting, November 18-19, 2008 - Transcript
	Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300

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