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FDA Panel Debates COVID Vaccine Recipe

FDA panel debates COVID vaccine recipe as questions swirl about fall shots

Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter.

The Boston Globe · 6d

FDA to issue new vaccine approval guidance amid questions over coronavirus shots

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump administration has introduced uncertainty into the annual process for green-lighting updated coronavirus shots traditionally offered in the fall.

Seattle Times · 1d

WA vaccine scientists push back against FDA changes around COVID shots

Seattle vaccine experts were confused by the country's apparent new direction around updated COVID-19 shots, which top FDA officials revealed Tuesday.

FDA, Covid

Forbes on MSN · 1d

FDA Changes May Limit COVID Vaccine Access—Drawing Some Criticism. Here’s What We Know

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new commissioner described as a “one-size-fits-all regulatory framework.”

Politico · 1d

FDA set to unveil new Covid vax guidelines today

FDA FLAGS SEVERE ITCH — Patients who stop using the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) may experience rare but severe itching after longtime use, the FDA has cautioned.

Reuters on MSN · 1d

FDA sets new COVID booster guidelines requiring trials for approvals for healthy adults

The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65, effectively limiting their availability later this year to older adults and those at risk of developing severe illness,

STAT1d

FDA will limit Covid vaccines to people over 65 or at high risk of serious illness, leaders say

The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of ...

22hon MSN

New FDA chiefs limit Covid-19 shots to elderly, sick

FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots ...

15h

FDA Commissioner Makary Cites Real Clear Journal Article At Panel On Talc In The American Food Supply

"Expert Panels with the FDA" are a series of roundtable discussions to provide an open public discourse on the latest medical and scientific information on several important topics. At this roundtable ...

Fierce Pharma1d

FDA lays out stricter COVID vaccine policy in pivot from 'one-size-fits-all' approach

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain ...

BioSpace3d

Makary’s ‘Conditional Approval’ Pathway for Rare Diseases Poses More Questions Than Answers

While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner ...

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