FDA Law Blog

MAY 13, 2024

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps.

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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 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. In the case of a non-agreement letter, FDA will provide its rationale for the decision.

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FDA Law Blog

JUNE 8, 2023

An estimated timeline for the return of in-person meetings has not been provided by CDRH. It is also noteworthy that in the March 27 announcement , FDA distinguished between teleconferences and videoconferences despite using the same online platform (e.g.,

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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

NOVEMBER 22, 2023

As described in the preamble to FDA’s proposed rule, recent toxicology studies in cooperation between FDA and the National Institutes of Health have provided “ conclusive scientific evidence ” for FDA to remove its authorization for BVO. Since then, FDA has evaluated new information on BVO’s possible health effects as it became available.

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FDA Law Blog

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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FDA Law Blog

NOVEMBER 16, 2021

5376 that has garnered the greatest amount of attention (at least in the food and drug law world) is TITLE XIII, Subtitle J (Drug Pricing), Part 1 (Lowering Prices Through Fair Drug Price Negotiation), Section 139001 (Providing for Lower Prices for Certain High-Priced Single Source Drugs). One of the new programs included in the H.R.

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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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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). In its complaint, Merck characterizes the Negotiation Program as coercive and draconian.

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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 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. 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

To implement the Tap Pilot, CDRH plans to build dedicated teams of advisors trained to provide feedback and advice tailored to the specific needs of each developer. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027). See Announcement. See Program Website.

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FDA Law Blog

NOVEMBER 21, 2022

To implement the Tap Pilot, CDRH plans to build dedicated teams of advisors trained to provide feedback and advice tailored to the specific needs of each developer. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027). See Announcement. See Program Website.

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FDA Law Blog

FEBRUARY 11, 2024

The three letters together provide the range of actions DEA may take: no rescheduling from schedule I (former drug officials), rescheduling to schedule III (Democratic state attorneys general), or descheduling altogether (Democratic senators). Letter 1 is signed by former DEA administrators and Directors of National Drug Policy.

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Physician's Weekly

JUNE 25, 2025

Health insurers will still be allowed to deny doctor-recommended care, which is arguably the biggest criticism that patients and providers level against insurance companies. Insurers also pledged to use clear language when communicating with patients and promised that medical professionals would review coverage denials.

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