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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FDA Communication Documentation 53

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).

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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. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).

Communication 59

Communication FDA 59

ISPE

NOVEMBER 23, 2022

Some of the highlights of the presentations given during the Symposium were as follows: The PIC/S Chairperson, Paul Gustafson, Health Canada, presented on PIC/S’ new strategic plan for 2023-2027 which covered the following elements: Promote, improve and monitor inspection reliance amongst PIC/S member authorities.

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Documentation FDA Communication 98

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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Communication 45

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.

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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.

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Insurance Compounding Dosage Communication 64