January 1, 2012
By:Jill Wechsler
Election-year politics will color a range of legislative and policy developments affecting drug development, production, and reimbursement in the coming year, as efforts to reduce government spending on healthcare prompts all parties to search for opportunities to do more with less. Looming over the political landscape is the upcoming Supreme Court decision on the constitutionality of the Obama health reform legislation.
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December 1, 2011
By:Jill Wechsler
FDA is under pressure to encourage medical product development, monitor an increasingly global supply chain, and accomplish everything with ever-tighter resources. In the last few years, Congress added tobacco oversight to FDA's plate and expanded oversight of food safety, on top of mandates speeding new therapies to market while ensuring they are safe and risk-free.
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November 18, 2011
By:Formulary staff
The American Medical Association has adopted a policy to help ease national drug shortages that threaten patient care and safety.
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November 1, 2011
By:Jill Wechsler
The outcry from physicians, pharmacists, and patients over disruptions in supplies of vital medicines to treat cancer, pain, and other serious conditions is drawing attention from the White House, Congress and the broader healthcare system.
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October 1, 2011
By:Jill Wechsler
It's flu season again, which always focuses public attention on the reliablity and availability of the nation's vaccine supply.
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September 1, 2011
By:Jill Wechsler
The push has begun for new policies to "improve" the drug approval process as all sides gear up to reauthorize prescription drug user fees next year.
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August 1, 2011
By:Jill Wechsler
FDA officials recently acknowledged that its established system for ensuring the quality and safety of drugs and other medical products cannot cope with significant changes in today's global medical market.
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July 1, 2011
By:Jill Wechsler
FDA is developing guidelines for documenting similarity and interchangeability of copycat versions of biotech therapies, a process that is drawing considerable scrutiny from a broad spectrum of stakeholders.
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June 17, 2011
By:Formulary staff
The Center for Drug Evaluation and Research recently announced that it will elevate the Office of Compliance to a Super Office to continue to ensure the safety, quality, and integrity of drugs in America, according to a memo from CDER Director Janet Woodcock.
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