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FDA Floats OTC Monograph Overhaul To Be “More Agile”

 
• By Malcolm Spicer

The agency will conduct a public hearing on March 25 and 26 for comments about improving the OTC monograph process, which currently faces “significant challenges.”

FDA is seeking to overhaul its OTC drug monograph process to be “more agile and responsive,” noting the current system faces “significant challenges.”

The agency will conduct a public hearing on March 25 and 26 at the agency’s headquarters in Silver Spring, Md.,...

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More from United States

US FDA Staff Stability Should Be A Congressional Priority, Former Chief Of Staff Says

 
• By Derrick Gingery

Lawmakers should address FDA staff upheaval and help the agency “get back on track,” former agency Chief of Staff Elizabeth Jungman said, while CBER Director Vinay Prasad told staff he is asking ex-colleagues to return to the agency.

US FDA ‘Commissioner’s Voucher’ As Public Relations Tool

 
• By Michael McCaughan

NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

US FDA Pediatric Adcomm To Examine HPV, Flu, Dengue Vaccines: No News Is Good News?

 
• By Sue Sutter

Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.

More from North America

Medicaid Changes Could Have Major Impact on Recent Coverage Improvements

 
• By Tim Casey

Insurance trade groups warned that the Big Beautiful Bill destabilize Medicaid and result in the largest ever roll-back in health care coverage in the US.

Drug Sponsors Can Help Shape Agenda For FDA/EMA Pediatric ‘Cluster’ Calls

 
• By Sue Sutter

Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.

Here At Last: Canada’s Long-Contested Guidelines For Curbing Excessive Drug Prices

 
• By Neena Brizmohun

Final guidelines explaining how staff at Canada’s Patented Medicine Prices Review Board should go about identifying drugs that could be considered for an excessive price hearing will come into force soon.