The FDA Law Blog

NOVEMBER 17, 2022

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S. Devices in the Safer Technologies Program (STeP) will be included in FY 2026. See Announcement. See Program Website.

Communication 69

Communication FDA 69

The FDA Law Blog

NOVEMBER 21, 2022

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S. Devices in the Safer Technologies Program (STeP) will be included in FY 2026. See Announcement. See Program Website.

Communication 59

Communication FDA 59

The FDA Law Blog

JUNE 14, 2023

In the ever-changing landscape of medical device development, FDA is touting steps it is taking that it says will enhance efficiency, foster innovation, and address key challenges faced by developers. It remains to be seen how FDA would define and actually implement the role of a TAP Advisor.

FDA 45

FDA Communication 45

PharmaShots

FEBRUARY 22, 2023

Some of its FDA-approved competitors include: Patents7 Eli Lilly carries big expectations from Trulicity to boost its revenue. In the US, Trulicity is protected by a compound patent (2027) and by biologics data protection (2026). Trulicity has been a part of over 2.8 million patients’ journeys with type 2 diabetes since 2014.

Insurance 64

Insurance Compounding Dosage Communication 64