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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ABIM

JUNE 12, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. For example, in specialties like cardiovascular disease and medical oncology with prevalent geriatric patient populations, concepts like frailty and falls may not be covered in assessment materials.

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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). 150,000).”

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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. Avadel has intervened as a Defendant, and neither FDA nor Avadel has yet to respond to the Complaint.

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FDA Law Blog

JUNE 14, 2023

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

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GeriPal

APRIL 3, 2025

That was actually Ken, you remember that article, Nancy Schoenberg’s article on screening and what to say and what not to say to patients on how to talk. How to talk to patients about screening colonoscopies. So therefore I feel that I am obligated to tell patients about this option. Ken 09:56 We did a role play.

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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. Studies have found that marijuana access has public health benefits by reducing the rates of opioid use and opioid deaths.

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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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