Executive Briefings

Could the FDA Become More of a Help Than Hindrance to the Pharmaceutical Industry?

The FDA could help medical device and pharmaceutical manufacturers bring new treatments and technologies to market by improving its scientific capabilities and collaborating more with the industry, says John Castellani, CEO of Pharmaceutical Research and Manufacturers of America, or PhRMA. The time from initial drug development research to final approval by the FDA can take 10 to 15 years, he said.

The FDA has apparently been listening to Castellani and others about the industry's concerns. On Oct. 5, the agency published a report called "Driving Biomedical Innovation: Initiatives to Improve Products for Patients." FDA Commissioner Margaret Hamburg identified seven major reforms in the report that the FDA plans to undertake.

This includes training for the next generation of innovators. The FDA plans to hire people who show outstanding promise in their fields to receive training in various industry disciplines, including design and development, manufacturing and regulatory affairs. The FDA also plans to develop a network of experts who will help the agency gain a better understanding of emerging technologies in fields where FDA reviewers might lack familiarity. Another area of focus for the FDA will be expedited drug development to speed up the clinical trial process.

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The FDA could help medical device and pharmaceutical manufacturers bring new treatments and technologies to market by improving its scientific capabilities and collaborating more with the industry, says John Castellani, CEO of Pharmaceutical Research and Manufacturers of America, or PhRMA. The time from initial drug development research to final approval by the FDA can take 10 to 15 years, he said.

The FDA has apparently been listening to Castellani and others about the industry's concerns. On Oct. 5, the agency published a report called "Driving Biomedical Innovation: Initiatives to Improve Products for Patients." FDA Commissioner Margaret Hamburg identified seven major reforms in the report that the FDA plans to undertake.

This includes training for the next generation of innovators. The FDA plans to hire people who show outstanding promise in their fields to receive training in various industry disciplines, including design and development, manufacturing and regulatory affairs. The FDA also plans to develop a network of experts who will help the agency gain a better understanding of emerging technologies in fields where FDA reviewers might lack familiarity. Another area of focus for the FDA will be expedited drug development to speed up the clinical trial process.

Read Full Article