Eye Drop Manufacturers Get Advice On Seeing Quality Clearly In US FDA Draft Guidance

Need for guidance shown not only in recalls over past year of OTC eye drops due to bacterial contaminants found in products and insufficient sterility practices in facilities but also in warning letters sent in 2022 and 2023 to firms manufacturing Rx and OTC ophthalmic drugs.

• Source: Shutterstock

The US Food and Drug Administration provides drug firms with a draft guidance on quality for eye drops and other topical ophthalmic products following a jump the past two years in contamination problems.

Need for the guidance was shown not only in recalls over the past year of OTC eye drops due to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight 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

More from Regulation

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

NDA User Fees Increasing 8.6% As FDA Projects More Applications But Fewer Sponsor Meetings

 

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

Self-Testing Kits Need To Be Regulated Like OTCs, UK Researchers Argue

 
• By 

Concerns raised by two recent studies prompt UK researchers to argue for greater regulation with regards to direct-to-consumer test kits.

More from Policy & Regulation

‘Classic Economic Injury’ Merits Plaintiffs’ Standing In Challenge To US FDA Homeopathic Regulation

 

Attorney Jonathan Emord says federal court’s grant of standing for Alliance for Natural Health USA and Meditrend to challenge FDA’s safety concerns about homeopathic drugs leaves open a door to continue arguing the agency violated multiple regulations by imposing NDA requirements for homeopathics.

NDA User Fees Increasing 8.6% As FDA Projects More Applications But Fewer Sponsor Meetings

 

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

Self-Testing Kits Need To Be Regulated Like OTCs, UK Researchers Argue

 
• By 

Concerns raised by two recent studies prompt UK researchers to argue for greater regulation with regards to direct-to-consumer test kits.