Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “Bayer Gets FDA Nod for App-Connected Injector for MS Patients,” by Jonah Comstock.

Following is an excerpt:

“On occasion, when a drug company was to get a new biological product approved, if they want a companion app, they can get that companion app approved through the same BLA,” Bradley Merrill Thompson, an attorney at Epstein Becker Green, explained to MobiHealthNews in an email. “In a similar way, for drug companies to get a new drug approved, if they want a companion app, can get that app approved through a new drug application. But quite honestly no one would ever describe an NDA or BLA as a preferable regulatory pathway to the 510(k). They are both very onerous, because they are principally directed at new biological products and drugs.”

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