During a conference call to announce Merck & Co.'s third-quarter results, the drugmaker's executives and analysts discussed how regulators in recent years have rejected some experimental drugs or required Merck to conduct additional studies to earn approval. That has held up a next-generation osteoporosis drug and an agent to reverse anesthesia after surgery, among other potential products.
QUESTION: With your recent announcement of plans to reduce funding for and reorganize your research operations, how will you improve your success rate in getting the Food and Drug Administration to approve your new medicines?
ANSWER: Over the last four years, we have had issues with study execution (and other challenges). ... We are doing a lot to improve safety data. I'm confident that we can work with FDA in a way that will bring (new drug applications) foreword that can pass muster.
- Health Care Industry
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