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COVID-19 Vaccines: BIO Pushes For EUA Guidance, While HHS’ Azar Downplays Its Importance

 
• By Sue Sutter

Guidance's release would provide regulatory clarity to scientists and strengthen public confidence in any vaccine authorized by the FDA, trade group says, but Alex Azar tells Congress the controversy over the unpublished document is overblown and making a ‘mountain out of a molehill.'

assorted molehills
To HHS' Alex Azar, the vaccine EUA guidance is a molehill turned into a mountain. • Source: Shutterstock

US Food and Drug Administration guidance on emergency use authorization for COVID-19 vaccines should be publicly released to provide regulatory clarity to scientists and researchers and strengthen public confidence in any vaccine authorized by the agency, the Biotechnology Innovation Organization says.

“All new FDA guidance should be finalized and communicated with those on the frontlines developing potential vaccines,” BIO president and CEO Michelle McMurry-Heath said in a 1 October letter to Health and Human Services secretary Alex Azar

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Global Pharma Guidance Tracker - April 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.