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Sunscreen TEAs Should Model Applications For Chronic-Use Cutaneous Drugs – FDA

 
• By Ryan Nelson

TEAs for UV filters should provide FDA with clinical safety data used to support approval of chronic-use cutaneous drugs and nonclinical testing should focus on potential long-term adverse effects, according to draft guidance required under the Sunscreen Innovation Act. FDA particularly is interested in comments about final formulation safety testing it anticipates requiring under specified monograph conditions.

FDA explains its expectations for safety and effectiveness data supporting sunscreen ingredient GRASE determinations in a draft guidance released on deadline and 10 months after the agency's tentative rejection of eight related time and extent applications.

Prepared for publication in the Nov. 23 Federal Register, the draft guidance – "Over-the-Counter Sunscreens: Safety and...

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More from United States

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

HHS Secretary Favors Regenerative Medicine Over Traditional Pharma: Blessing And Curse?

 
• By Sarah Karlin-Smith

Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.

‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 
• By Bridget Silverman

With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

More from North America

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By Cathy Kelly

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.