Never Mind Next-Gen UV Filters; Existing Sunscreen Ingredients’ GRASE Status May Be In Danger

FDA aims to publish a tentative final monograph for OTC sunscreen drugs in 2019 that identifies “data gaps that FDA believes need to be filled” for 16 currently listed UV filters to support their continued marketing in the US without new drug approvals.

FDA entrance sign 2016

The US Sunscreen Innovation Act, signed into law in late 2014, requires FDA to amend and finalize its long-stayed regulations regarding nonprescription sunscreen active ingredients within five years of the SIA’s enactment.

More from Regulation

Eisai Switches Proton Pump Inhibitor Rabeprazole To OTC In Japan

 
• By 

Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.

German Industry Urges ECHA To Reconsider ‘De Facto’ EU Ethanol Ban

 
• By 

Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.

AESGP: ‘No Evidence’ Of Antimicrobial Resistance With OTC Antifungals Or Antivirals

 
• By 

Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.

Over The Counter: What To Expect From The 61st AESGP Annual Meeting, With Jurate Švarcaite

 
• By 

HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.

More from Policy & Regulation

German Industry Urges ECHA To Reconsider ‘De Facto’ EU Ethanol Ban

 
• By 

Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.

AESGP: ‘No Evidence’ Of Antimicrobial Resistance With OTC Antifungals Or Antivirals

 
• By 

Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.

Over The Counter: What To Expect From The 61st AESGP Annual Meeting, With Jurate Švarcaite

 
• By 

HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.