FDA taps Genaera's anti-angiogenic squalamine for its Continuous Marketing Application Pilot 2 program, the firm announces Jan. 4. Squalamine was selected by CDER's Division of Anti-Inflammatory, Analgesic and Ophthalmic Drug Products; the program provides frequent scientific feedback and interaction during the IND phase, with each review division choosing one participant. Squalamine is being developed for "wet" age-related macular degeneration. Phase II trials are underway, with data expected in the first quarter. Genaera plans to begin Phase III in the first half of 2005, to run concurrently with its largest Phase II study...

Vacci Prep is first “supplement to establish a standard of care for consumers when preparing their immune system for vaccinations,” Dentovations says.

Effective medical device regulation supports both safety and innovation needs. This article assesses how well the US FDA and the Australian TGA achieve this balance.