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FDA Combs Out Knotty Development Issues For Head Lice Products

 
• By Brenda Sandburg

Draft guidance notes special safety considerations for the treatments, which would usually be used on healthy kids.

For parents head lice is one of the scourges of winter. Now that snow storms have hit many parts of the country leaving kids stuck inside, sponsors could have an increased incentive to ponder a draft FDA guidance on developing topical drugs to treat the problem.

The guidance, "Head Lice Infestation: Developing Drugs for Topical Treatment," notes that there are many approved drugs to...

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More from United States

Cancer Drug Combos: US FDA Guidance Offers Options Beyond Factorial Trials

 
• By Manas Mishra

Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.

US FDA Rare Disease Hub RISEs After Slow Start

 
• By Michael McCaughan

The first “Rare disease Innovation, Science and Exploration (RISE) meeting to discuss the choice of control arms for studies in small populations will be Sept. 3 after plans were delayed by ongoing changes at the FDA.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

More from North America

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 
• By Sarah Karlin-Smith

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.

Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.

Inside Elamipretide’s CRL: Clinical And Surrogate Evidence Deficiencies, And A Path Forward

 
• By Sue Sutter

The Pink Sheet takes an exclusive look at the complete response letter, which shows the information on application deficiencies that could become widely available if FDA leaders succeed in releasing CRLs in real time.