1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

FDA Faults BASF Sunscreen Ingredient Data In Latest TEA Rejection

 
• By Malcolm Spicer

FDA advises BASF that the information the firm submitted is not sufficient to establish octyl triazone as GRASE. The agency’s third rejection this year of a sunscreen TEA could concern advocates on Capitol Hill and in the industry for using the process for adding ingredients to the OTC sunscreen monograph.

BASF AG’s time and extent application does not support adding octyl triazone to the OTC sunscreen monograph, FDA says in its third finding this year that a TEA for sunscreen ingredients is inadequate.

FDA’s decisions on the three TEAs could concern advocates on Capitol Hill and in the industry who want to use...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

 
• By Francesca Bruce

Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?

 
• By Derrick Gingery and Mandy Jackson

One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.

Advocates Want New Bipartisan PBM Reform Package To Stand Alone

 
• By Leslie Small

A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.

Business Background Of New CDER Director George Tidmarsh

 
• By Bridget Silverman

George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.

More from North America

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
• By Urtė Fultinavičiūtė

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy

 
• By Sue Sutter

Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."

Will Tidmarsh’s Industry Experience Translate As US FDA’s Chief Drug Regulator?

 
• By Sarah Karlin-Smith and Derrick Gingery

The long-time industry executive led several drug approvals but may have a lot to learn about the intimate details of application review and the Center for Drug Evaluation and Research.