Covid-19 roundup: FDA has fi­nal­ly post­ed dis­cus­sion items for to­mor­row's ad­comm; As­traZeneca could soon re­sume US vac­cine tri­als

It may have come a day late, but the FDA has fi­nal­ly post­ed the dis­cus­sion items that its out­side ex­perts will re­view dur­ing to­mor­row’s ad­comm on the new wave of Covid-19 vac­cines now in the clin­ic.

There are no spe­cif­ic vac­cines or da­ta to dis­cuss. In­stead, the agency wants feed­back on its over­all ap­proach. And they’re will­ing to go late in­to the evening to get it.

Here’s the run­down:

1. Please dis­cuss FDA’s ap­proach to safe­ty and ef­fec­tive­ness da­ta as out­lined in the re­spec­tive guid­ance doc­u­ments.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER