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Your search keyword '"Kesselheim, Aaron S."' showing total 2 results
Start Over Author "Kesselheim, Aaron S." Topic drug approval Topic therapeutics Journal new england journal of medicine
2 results on '"Kesselheim, Aaron S."'

1. The FDA Breakthrough-Drug Designation - Four Years of Experience.

Author

Darrow, Jonathan J., Avorn, Jerry, and Kesselheim, Aaron S.

Subjects
*ANTI-infective agents, *INDUSTRIAL statistics, *DRUG approval laws, *INVESTIGATIONAL drugs, *DRUG design, *TUMORS, *DRUG approval, *SYMPTOMS, *THERAPEUTICS
Abstract

The article discusses the breakthrough therapy designation created by U.S. Congress to expedite Food and Drug Administration testing as well as approval of drugs aimed at treating serious diseases. Manufacturers were allowed to employ many programs to combine different advantages which reduced cost of drug development.

Published
2018
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2. Ensuring Access to Injectable Generic Drugs - The Case of Intravesical BCG for Bladder Cancer.

Author

Davies, Benjamin J., Hwang, Thomas J., and Kesselheim, Aaron S.

Subjects
*BCG immunotherapy, *CANCER chemotherapy, *ANTINEOPLASTIC agents, *BCG vaccines, *GENERIC drugs, *HEALTH services accessibility, *MEDICAL care costs, *DRUG approval, *INTRAVESICAL administration, *THERAPEUTICS, *ECONOMICS, BLADDER tumors
Abstract

The article discusses the access to injectable generic drugs, with focus on bacille Calmette-Guérin for bladder cancer. It notes the prospect of a sustained shortage or substantial price increase after a BCG manufacturer announces in November 2016 to exit the market in mid-2017. It illustrates the price increase of mitomycin, thiotepa, and valrubicin during the BCG shortage beginning in 2014. Also noted is payment reforms which could further stabilize the generic injectable agents market.

Published
2017
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