Bethany Hills spoke to Bloomberg Law about how her practice in the healthcare and pharmaceutical industries has changed during the coronavirus pandemic.
According to Bethany, the FDA has been uncharacteristically quick to respond to requests for Emergency Use Authorization for diagnostics and other COVID-related products. “When we have general questions they get answered within 24 hours,” Bethany said. “In the non-COVID world, that is not our experience. It can be a really long time to get on the FDA’s calendar – sometimes meetings take weeks to months to get scheduled. This has been a breath of fresh air to interacting with the FDA.”
Bethany said that there are also challenges here as well, and that she and others are scrambling to keep up with a steady stream of FDA policy changes for companies developing virus-related diagnostics, treatments, and vaccines. Lawyers have “frustrations with how this is rolling out,” according to Bethany. “There are just so many FDA policies and there’s so much activity, we have a whole team of people trying to stay up to date. It literally changes on a day-to-day basis.”
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