FDA Law Blog

OCTOBER 24, 2022

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. There will be two submission deadlines per year on March 31 and September 30, through March 31, 2027.

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FDA Law Blog

OCTOBER 6, 2023

The Proposed Rule states that Stage 4 and Stage 5 would not begin before October 1, 2027, and April 1, 2028, respectively, in order to enable laboratories to participate in negotiations preceding user fee reauthorization in 2027 (taking effect in FY2028, which begins on October 1, 2027).

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FDA Law Blog

APRIL 14, 2022

MDUFA V would be applicable to fiscal years 2023 through 2027. The draft MDUFA V commitment letter starts with a 70% goal in FY 2023, but if the de novo decision goal is met in FY 2023 and the fee revenue amount provided for FY 2026 and 2027 is adequate to support performance improvements, FDA plans to increase the goal to 80% in FY 2026.

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FDA Law Blog

AUGUST 23, 2023

By the end of Q2 FY 2023, FDA will convene the first of a series of 5 public meetings or workshops with key stakeholders including patients, biopharmaceutical companies, DHT companies, and academia to gather input into issues related to the use of DHTs in regulatory decision-making.

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FDA Law Blog

JULY 24, 2023

Specifically, FDA determined that Avadel’s Lumryz can “break” Jazz’s ODE because it is “clinically superior” based on Lumryz’s “major contribution to patient care,” rendering it not “the same drug” under the Orphan Drug Act. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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GeriPal

APRIL 3, 2025

Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. So this is something. This is the plenary to attend. It is a sold out crowd. It is a standup crowd and it’s going to be a hard act to follow. Of course. We will step aside. Speaker 6 03:29 Andy.

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FDA Law Blog

JUNE 14, 2023

In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).

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FDA Law Blog

NOVEMBER 17, 2022

patients are “first in the world” to receive innovative medical devices that are of “high-quality, safe, and effective” through “early, frequent, and strategic communications between the FDA and medical device sponsors.” 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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FDA Law Blog

NOVEMBER 21, 2022

patients are “first in the world” to receive innovative medical devices that are of “high-quality, safe, and effective” through “early, frequent, and strategic communications between the FDA and medical device sponsors.” 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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Medical Patient-Centered Provider IT 59

FDA Law Blog

FEBRUARY 11, 2024

The regulated cannabis marketplace brings in billions of dollars in revenue into state and federal governments, with predictions that cannabis sales will exceed $53 billion by 2027. Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. In other words, no rescheduling.

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Physician's Weekly

JUNE 25, 2025

Insurers also pledged to use clear language when communicating with patients and promised that medical professionals would review coverage denials. But health policy analysts say prior authorization — a system that forces some people to delay care or abandon treatment — may continue to pose serious health consequences for affected patients.

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