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US FDA Gains Budget Increase In FY 2017… And Not Through Fees

 
• By Derrick Gingery

Omnibus legislation to fund the federal government for FY 2017 includes an increase in non-user fee funds, which should please stakeholders.

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FDA could receive an increase in non-user fee dollars for fiscal year 2017 in a new budget agreement, but FDA's drug, biologic and device centers still would see their budgets decrease.

House and Senate appropriators reached an agreement on a proposed fiscal year 2017 omnibus appropriations bill April 30, which would fund the federal government through the end of September and stave off a potential

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US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
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FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
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At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.

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Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
• By Vibha Sharma

While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
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US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
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Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.