Articles by Amy Ritter - Pharmaceutical Technology

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Articles by Amy Ritter

Single-use Technologies in Fill–Finish Operations

Single-use components in the fill–finish line provides increased flexibility to multiproduct manufacturers.
Oct 2, 2011

Single-use components in the fill–finish line provides increased flexibility to multiproduct manufacturers.

New FDA Guidance on User Fee Waivers, Reductions, and Refunds

Sep 29, 2011

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.

White House Deficit Reduction Plan Targets Biologic Exclusivity Period

Sep 22, 2011

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.

Novo Nordisk Launches Diabetes Program in India

Sep 15, 2011

Novo Nordisk announced the roll-out of its Changing Diabetes in Children program in India, making India the seventh country to participate.

Generic Drug User Fee Agreement Nears Completion

Sep 8, 2011

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.

Drug Shortages Loom Large

Aug 25, 2011

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.

Pfizer Discloses Potentially Improper Payments

Aug 18, 2011

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.

For Biosimilars, No “One Size Fits All”

Aug 11, 2011

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.

2012 Prescription Drug User Fees Announced

Aug 4, 2011

FDA announced in late July the 2012 user fees collected under the Prescription Drug User Fee Act of 2007.

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