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Adasuve’s Extensive REMS Proposal Raises Questions About Whether It Could Work In Practice

 
• By Derrick Gingery

Patient screening to ensure pulmonary risks are mitigated could be difficult in emergency room settings, advisory committee says about inhaled loxapine formulation.

The real-world application of an extensive risk management plan seemed to vex several members of the Psychopharmacologic Drugs Advisory Committee as they considered Alexza Pharmaceuticals Inc.’s Adasuve, an inhaled formulation of loxapine.

Ultimately, the group sent a mixed signal on whether to recommend approval of the product. The 9-8 vote, with one...

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More from US FDA Performance Tracker

October US FDA User Fee Goals: Few Novel Agents, But Many New Indications As Shutdown Looms

 
• By Bridget Silverman

October is unusually low on user fee goals for novel agents, but more than 20 applications for new indications and formulations will keep FDA staff busy, especially in oncology and ophthalmology.

J&J’s Inlexzo Is A Rare 505(b)(2) NDA To Qualify For US FDA’s Real-Time Oncology Review

 
• By Bridget Silverman

A Johnson & Johnson executive tells the Pink Sheet in an interview how the company developed its pretzel-shaped intravesical drug releasing system for gemcitabine, which used design and materials to improve efficacy and ease bladder cancer treatment.

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.

Rare Disease Tests Aplenty On US FDA’s September User Fee Calendar

 
• By Bridget Silverman

US FDA's regulatory flexibility for rare diseases is newly enshrined in the FDA's "Rare Disease Evidence Principles," but upcoming goal dates include some real-world examples of challenging orphan applications.

More from Regulatory Trackers

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.

Rare Disease Tests Aplenty On US FDA’s September User Fee Calendar

 
• By Bridget Silverman

US FDA's regulatory flexibility for rare diseases is newly enshrined in the FDA's "Rare Disease Evidence Principles," but upcoming goal dates include some real-world examples of challenging orphan applications.

US FDA Emphasizes Primary Endpoint Primacy In Vatiquinone, Lytenava CRLs

 
• By Bridget Silverman

The complete response letters call for a new trial for PTC’s vatiquinone and more confirmatory evidence for Outlook Therapeutics’ Lytenava, while Telix’s Zircaix CRL shows quality challenges for a novel radiopharmaceutical approach.