Bradley Merrill Thompson Quoted in “CDRH Looks Ahead, and Behind, on Guidance Development”

The Gray Sheet

Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Gray Sheet, in “CDRH Looks Ahead, and Behind, on Guidance Development,” by David Filmore. (Read the full version — subscription required.)

Following is an excerpt:

"I am very encouraged by the notion that they want to get earlier input," said Bradley Merrill Thompson, an attorney that has engaged FDA on improving the guidance process as the organizer of the Combination Products Coalition and the mHealth Regulatory Coalition. "That was a big point industry was making, that they should get input before they put a draft together because drafts then take on a life of their own. So they are at least taking steps in that direction."

But, Thompson said he would like to see the agency adopt more modern methods that would allow regulators to routinely gather technical feedback before guidance writing begins.

"Frankly, it would be very cheap to get early input if FDA would start using social media and other 21st-century technologies to float ideas and get feedback," Thompson said.