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# FDA to Tweak Industry/Reviewer Communications: Makary
- URL: https://www.fdaweb.com/fda-to-tweak-industry-reviewer-communications-makary/
- Published: 2025-06-11T12:00:00.000Z
- Updated: 2026-09-14T15:14:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159345

FDA commissioner **Marty Makary** says the agency will improve the communication channels between reviewers and companies to help speed innovation and medical product development. Makary shared this upcoming improvement in a just-posted [podcast](https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.youtube.com/watch%3Fv%3D96aXvMKCN9o&ved=2ahUKEwj6rOfQxuqNAxUwKlkFHUS9CXsQwqsBegQIFRAF&usg=AOvVaw3eHL5lgcmUWb4qAtbHwmiF) that discussed some of the feedback he and other officials are receiving as part of an ongoing [listening tour](https://www.fda.gov/industry/ceo-forums-fda-listening-tour-engage-pharma-ceos?ref=fdaweb.com) with CEOs from big and small companies.

Makary said the agency heard from companies that a simple “five-minute call could save them two months of back and forth with letters or uncertainty.” Questions about an application being prepared or which clinical trial design to choose could be handled through a less formal communication format, he said. “So companies and developers deserve an instant response to their questions. And of course, we can’t let them abuse it where they’re calling five times a day with every little detail, but a couple of quick response communications would go a long way. So we’re gonna work on that.”

Another concern raised by industry that FDA will try to improve involved chemistry, manufacturing and controls information that is included in product applications, CBER director **Vinay Prasad**, who is participating in the listening sessions, said in the podcast. “Industry’s point of view is that meeting all of these standards can be extremely onerous and costly and time consuming,” he said. “So we hear them, but… the products that we have in this country have to be the highest quality/sterility when necessary. I'm sure the industry has a point that our paperwork is at times overly bureaucratic, and too many forms and too many pages.”

Another category that came up during the session was endpoints, control arms, randomization, and when they are needed, according to Prasad. He said industry wants more predictability, and what the agency is looking for in certain tailored cases. Makary said this could also be addressed when the agency thinks “about ways we can have a faster talking back and forth with our reviewer staff. 

“I think anything we can do to reduce mind reading at the FDA, the better,” Makary continued. “I mean, predictability is important. It’s important not just for companies and developers, but it's important for investment, right? We want to encourage investment in innovation and so predictability cuts through one of the big problems in life, in all aspects of life, and that is making assumptions right? So the more we can do to let folks know this is exactly what we are thinking the better.”

Additionally, industry suggested that FDA could find ways to share the different reasons why some hopeful products didn't come to market, such as the manufacturing reasons, efficacy reasons, endpoint reasons. Prasad said there’s got to be a way that industry can learn from all that information, so that they don’t repeat the mistakes, “and we are going to look into that.”