Zachary Brennan

RFK won’t testify before key Senate committee this week on HHS overhaul - https://t.co/lnv7ZVj4e4

Sharfstein on $NVAX delay for its EUA to BLA conversion: FDA needs to explain what’s going on and why. To do it in such an opaque way doesn’t help

Re Five office memo - to fold all the offices into one/multiple? Sharfstein: The different products require different science, different law, different policies. What could go wrong? (Laughter)

Sharfstein: There’s no budget cut. There’s no external reason to do these staff cuts at FDA. We’re talking about people who schedule inspections - “they were treated terribly.”

Sharfstein: When Kennedy said he was making mistakes on layoffs, “that blew my mind.” First order of biz needs to be: who can we bring back?

RT @Laura_H: AI panel: Novartis' Nicole Mahoney notes importance of reg certainty and of guidance. "Guidance isn't only for the pharmaceuti…

Woodcock to #BPC: we don’t know what this admin’s policy positions are with regard to evidence generation or user fee negotiations (supposed to kick off in the fall)

Woodcock to #BPC: This is a slow moving catastrophe. All focus will be on IND reviews and pending NDAs/BLAs/supplements, while sponsor meetings/guidance development will fall to the wayside FDA will be reluctant to approve products if they can’t get to the sites for inspections

Woodcock tells #BPC: Most worrisome is that inspectors don’t have the travel help they need for foreign inspections — “can’t plan them on their own”

Former FDA leader Frank Sasinowski tells #BPC he had two meetings last week w CDER and CBER - impressed by the staff’s continued dedication but the campus looks like a “zombie movie set”

RT @SarahKarlin: and on Novavax app: Marks said he would have resigned after the FDA missed the deadline for the approval decision, if he h…