Gottlieb: New types of drug products may require more medical-device style evaluations

Friday, September 8, 2017

With the coming influx of new types of medical technology like the recently approved gene therapy cancer treatment CAR-T, FDA needs to shift the way it evaluates safety and effectiveness, Commissioner Scott Gottlieb said in a speech Thursday.

Many new products like CAR-T are administered once but have long-term effects, making it hard to evaluate the risk-benefit ratio. As a result, Gottlieb said drug-type products may need to be evaluated in a way that is more similar to FDA's current evaluation process for medical devices, including more emphasis on the post-marketing stage, he said. Sarah points out that the medical device review process is generally shorter and less stringent than the drug approval process.

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