HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Ophthalmic Drug Dispensers Being Reclassified In US As Combo Products Get Regulatory Leeway

Executive Summary

US FDA gives 12 month grace period for ophthalmic products once regulated as drugs to comply with requirements for combination products and temporarily exempts lower-risk constituents. Guidance specifies changes agency is making in response to Genus Medical v. FDA decision.

You may also be interested in...

Combination Product Human Factors Final Guidance In Clearance, OCP Says

The OCP presented its priorities for 2023 and beyond at the RAPS/AFDO Combination Products Summit on 8 November.

US FDA’s Reclassification Of Certain Drugs As Devices May Be 'Seismic Event' For Some

Sponsors are receiving information requests and complete response letters as a result of the agency’s transition plan, which was made in response to the Genus v. FDA ruling. The decision's aftershocks could reshape the landscape for a number of products, attorney says.

Imaging Drugs Make Jump To Devices In New Decision By FDA

After losing the recent Genus Medical Technologies court case, the US FDA will begin transitioning certain imaging agent drugs to devices.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts