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Possible Orange Book Revisions Back In Play With US FDA Report To Congress

 
• By Brenda Sandburg

Agency is setting up an internal working group to assess whether certain patent information should be included or removed from the Orange Book. PhRMA, AAM and others address therapeutic equivalence ratings and listing of device-related and REMS-related patents.

US FDA is evaluating whether to make improvements to its Orange Book • Source: Alamy

The Orange Book Transparency Act signed into law last year required the US Food and Drug Administration to solicit public comments on what patent information should be included in the Orange Book. The agency had already completed this task, so it reopened the docket for further input and is now evaluating possible revisions to the publication.

Last month, the FDA submitted a report to Congress summarizing the comments it received without specifying who made the comments or responding to them. The agency also noted that...

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The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

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

 
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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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Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
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The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

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

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.