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CDER Asked To Shed More Light On Potential Monograph User Fees

 
• By Malcolm Spicer

While Director Janet Woodcock and other CDER officials explain the center's reasons for proposing a monograph program user fee, some stakeholders suggest the agency explain more about how the program would work.

Most drug industry stakeholders agree that FDA needs additional funding to regulate the OTC sector and make more self-care products available, but some need convincing the agency is on the right track looking at a potential user fee for the OTC monograph program.

At a June 10 public meeting, Center for Drug Evaluation and Research Director Janet Woodcock and other officials explained the...

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More from United States

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
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US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

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Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

More from North America

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.