FDA Law Blog

OCTOBER 24, 2022

The website describes three eligibility criteria: The sponsor has an IND or pre-IND number for the medical product; The proposed RWE is intended to meet regulatory requirements in support of labeling for effectiveness or to meet post-approval study requirements; and.

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FDA Law Blog

OCTOBER 8, 2021

Livornese — As surveyed in detail by our colleagues in an earlier blog post , FDA’s PDUFA VII goals letter , for fiscal years 2023-2027, is full of announcements and new agency initiatives. Medical Policy and Program Review Committee, Medical Policy Coordinating Committee, and Pediatric Review Committee). By McKenzie E.

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FDA Law Blog

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. By following these tips, industry may be able to foster a productive and constructive engagement with FDA, leading to favorable outcomes for the development of new medical products and a strengthened relationship going forward.

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FDA Law Blog

OCTOBER 6, 2023

The end of enforcement discretion The PR proposes to phase out LDT “enforcement discretion” over a period of four years, after which most LDTs will be subject to all applicable medical device regulatory requirements. Whether academic medical centers should be treated differently than other laboratories offering LDTs.

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FDA Law Blog

APRIL 14, 2022

Cato — On March 22, FDA announced that it reached agreement with representatives from the medical device industry on proposed recommendations to Congress for the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V). MDUFA V would be applicable to fiscal years 2023 through 2027.

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FDA Law Blog

AUGUST 23, 2023

By Adrienne R. The DHT steering committee includes senior staff from CDER, CBER, CDRH, including the Digital Health Center of Excellence (DHCoE), the Oncology Center of Excellence, and the Office of Clinical Policy and Programs.

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FDA Law Blog

JULY 24, 2023

With that decision, Jazz lost its ODE, allowing Avadel’s sodium oxybate product to compete with Jazz’s long before the expiration of the ODE covering Jazz’s most recent product, Xywav, in 2027.

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FDA Law Blog

NOVEMBER 21, 2022

The TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027). By Adrienne R. Food & Drug Admin.,

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Medical Patient-Centered Provider IT 59

FDA Law Blog

NOVEMBER 9, 2022

In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several drug, biological product, and medical device user fee provisions that were scheduled to sunset on September 30, 2022, FUFRA reauthorizes—but only through December 16, 2022—several other statutory provisions that were scheduled to expire.

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FDA Law Blog

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027). up to 125 total products enrolled through FY 2025).

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FDA Law Blog

NOVEMBER 17, 2022

The TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027). Food & Drug Admin.,

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Patient-Centered Provider Medical IT 69

GeriPal

APRIL 3, 2025

So I went to medical school in Chicago and I got engaged in Chicago, and that night we went to a blues club with my sister and my husband, which was really fun. But for 2027, if anyone watched the state voting at the Democratic Convention, which is usually a very boring thing, but this last presidential cycle, it was actually very fun.

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FDA Law Blog

JANUARY 29, 2025

Aside from his many high profile claims about vaccines, what he perceives as corruption at FDA, and his promise to go wild on health, Kennedys specific policy preferences about how FDA should administer its day-to-day oversight of drugs, medical devices, food, dietary supplements, cosmetics, or tobacco have not been publicly detailed.

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FDA Law Blog

FEBRUARY 11, 2024

The former officials implore following the science demonstrating marijuana’s high addictive potential, its lack of accepted medical use, and the rescheduling impact on prosecuting drug trafficking organizations. and lacks an acceptable level of safety for use even under medical supervision. In other words, no rescheduling.

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Physician's Weekly

JUNE 25, 2025

Dozens of insurance companies, including Cigna, Aetna, Humana, and UnitedHealthcare, agreed to several measures, which include making fewer medical procedures subject to prior authorization and speeding up the review process. Insurers also pledged that medical professionals would continue to review prior authorization denials.

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