Representative experience

Approaching FDA with client concerns regarding the development and approval process for devices referencing drug products.

Assisted clients in drafting comments to FDA’s devices referencing drugs hearing notice.

Helping reverse an FDA decision that would have required new drug approval of a women’s health combination product and, instead, determined that the client’s product would require only 510(k) clearance as a medical device.

Preparing a request for designation letter on behalf of the sponsor of an accessory to an ophthalmic procedure, helping ensure that the accessory would be regulated by the FDA as a device rather than a drug.

Preparing a pre-RFD request designed to classify a topical dental product as a device instead of a drug.

Securing a designation of a small European biotechnology company’s product as a biologic rather than a new drug, a more advantageous designation considering future would-be competitors.

Helping a client whose drug was already approved in Japan to map out the Japanese regulatory pathway for a novel implanted drug delivery system.

Counseling a client on the EU regulatory pathway and optimal business strategy for developing a novel combination product comprised of recombinant human cells encased in a device implant.

Filing numerous RFDs that have successfully persuaded the FDA to regulate our client’s device-drug combination product in CDRH under the device authorities.

Our clients desired this result because they perceived regulation in CDRH under the device authorities as less onerous than the alternatives.

Assisting clients in developing and discussing with FDA novel test methods to evaluate chemical, physical, and biological modes of action for combination products and complex novel single entity products.

Assisted a client in determining the regulatory obligations applicable to its drug delivery system in the EU.