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Single-use components in the fill–finish line provides increased flexibility to multiproduct manufacturers.
Oct 2, 2011
By:
Amy Ritter
Single-use components in the fill–finish line provides increased flexibility to multiproduct manufacturers.
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Sep 29, 2011
By:
Amy Ritter
FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA's policies for issuing waivers, refunds or reductions in prescription drug user fees.
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Sep 22, 2011
By:
Amy Ritter
President Obama released his plan for deficit reduction on Sept. 19, 2011, and included in the 80-page report are several provisions that would affect US drug makers if enacted.
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Sep 15, 2011
By:
Amy Ritter
Novo Nordisk announced the roll-out of its Changing Diabetes in Children program in India, making India the seventh country to participate.
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Sep 8, 2011
By:
Amy Ritter
Representatives from FDA, the Generic Pharmaceutical Association, the European Fine Chemicals Group, and a task force from the Society of Chemical Manufacturers and Affiliates are nearing completion of draft legislation for the Generic Drug User Fee Act.
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Aug 25, 2011
By:
Amy Ritter
In 2010, FDA recorded nearly 180 drug shortages, triple the number recorded in 2005. Most of the drugs that experienced shortages were sterile injectables, including cancer medications and anesthetics.
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Aug 18, 2011
By:
Amy Ritter
In its latest filing with SEC for the quarter ending July 2011, Pfizer indicated that it has voluntarily provided the SEC and DOJ with information concerning potentially improper payments made by Pfizer and Wyeth in connection with sales activities that took place outside of the United States.
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Aug 11, 2011
By:
Amy Ritter
Since the passage of the BPCI Act in 2009, manufacturers have been waiting for guidance from FDA on what that approval process will look like.
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Aug 4, 2011
By:
Amy Ritter
FDA announced in late July the 2012 user fees collected under the Prescription Drug User Fee Act of 2007.
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