FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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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).

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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. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.

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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

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. By McKenzie E.

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FDA Law Blog

AUGUST 23, 2023

By Adrienne R. By end of Q2 FY 2023, FDA will enhance its internal systems to support review of DHT-related submissions including capturing key information about clinical trials utilizing DHTs to support tracking the number and rate of change of DHT related submissions.

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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. Though the Orphan Drug Act (now) includes a clinical superiority clause, Jazz argues that it is not a third exception to ODE. .

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GeriPal

APRIL 3, 2025

We covered: The first parody song I wrote, for AGS 2018 in Orlando , about this article by Nancy Schoenborn on how to discuss stopping cancer screening. 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.

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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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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. Given Dr. Shuren’s propensity to use the phrase, we have yet to see it formally defined by CDRH.

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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., See Program Website.

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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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