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Hahn Says COVID Vaccine Review Could Take Months As Trump Floats Rejecting New EUA Guidance

 
• By Sarah Karlin-Smith

Commissioner’s comments were yet another sign that US FDA won’t clear a vaccine ahead of the election, but hours later the president suggests the White House may decline to clear the agency’s new guidance on emergency use authorization standards for COVID-19 vaccines, raising new concerns about political interference in any decisions.

FDA Commisioner Hahn, NIAID Director Fauci, CDC Director Robert Redfield and HHS's Brett Giroir testify at the Senate HELP Committee on 23 September 2020
FDA Commisioner Hahn, NIAID Director Fauci, CDC Director Robert Redfield and HHS's Brett Giroir testify at the Senate HELP Committee

It typically takes the US Food and Drug Administration weeks to months to review a vaccine application after it is submitted to the agency, Commissioner Stephen Hahn told Senators on 23 September when asked how long it will likely take the agency to reach a decision on a COIVD-19 vaccine once an application is filed.

The admission casts further doubt on the likelihood a COVID-19 vaccine could receive an approval or emergency use authorization before the November 2020 US elections which, are five

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Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

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• By Derrick Gingery

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Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
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US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

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ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.