2027 Communication FDA 
The FDA Law Blog
SEPTEMBER 16, 2024
Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.
The FDA Law Blog
JUNE 8, 2023
The pandemic had changed the way people live, work and communicate. FDA has begun to reintroduce in-person meetings. It is also noteworthy that in the March 27 announcement , FDA distinguished between teleconferences and videoconferences despite using the same online platform (e.g., However, not all changes are forever.
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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. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).
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. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).
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.
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.
The FDA Law Blog
JUNE 7, 2023
Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). Second, Merck argues that the parody of a negotiation and a fair price compels speech in violation of the First Amendment.
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