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US FDA Fulfills Annual Antibiotic Guidance Goal With Three Women’s Health Guidances

 
• By Bridget Silverman

Final guidance documents for bacterial vaginosis, vulvovaginal candidiasis, and uncomplicated urinary tract infections contain few changes from draft.

The US Food and Drug Administration met its annual commitment to review and revise at least three guidance documents related to antibiotics or antifungals in just one day earlier this year, with the simultaneous release of final guidance documents on developing drugs for treatment of three common infections in women: bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and uncomplicated urinary tract infection (uUTI, which only occurs in women).

The guidance documents bring FDA closer to the culmination of a nearly decade-long project of revisiting its advice to antibiotic sponsors

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Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
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A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

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Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

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US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By Sue Sutter

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.