The Medical Futurist

MAY 18, 2025

By 2027, global surgical robotics sales are expected to reach $14.8 Assisting surgeries, disinfecting rooms, dispensing medication, keeping company: believe it or not these are the tasks medical robots will soon undertake in hospitals, pharmacies, or your nearest doctor’s office. But there is undoubtedly impressive progress.

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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. We, and many stakeholders, agree that RWD and RWE can play an invaluable role. Congress has recognized the challenges with FDA’s acceptance of RWD and RWE.

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FDA Law Blog

OCTOBER 24, 2022

There will be two submission deadlines per year on March 31 and September 30, through March 31, 2027. 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.

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ABIM

JUNE 12, 2025

Ruiz, MD, Chair, ABIM Geriatric Medicine Board The Geriatric Medicine Board , which meets twice a year and is responsible for oversight of policy and assessment in the specialty, held its spring meeting on March 28, 2025. 4,372 of these (92%) also have a current valid certificate in Internal Medicine. Community Practice in ABIM Governance* Erica N.

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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. FDA’s decision will take the form of an “agreement letter” or a “non-agreement letter.”

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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

JUNE 8, 2023

Soon after, the Agency announced beginning on March 27, 2023, the FDA generic drug program would resume in-person FTF meetings, but caveated that the in-person FTF meeting option would only be available for pre-ANDA product development meetings and pre-submission meetings for which the applicant requests this in-person FTF meeting format.

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FDA Law Blog

OCTOBER 12, 2023

Industry has been asking for Suitability Petition reform for years, either by FDA or mandated by Congress, but, other than a few rejected bills , such requests have basically gone nowhere. Under 21 C.F.R. FDA now has committed under GDUFA III to actually reviewing Suitability Petitions. covering ANDA Suitability Petitions.

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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

Moreover, California recently enacted the California Food Safety Act , prohibiting the manufacturing, selling, delivering, distributing, or holding food that contains BVO, with a $5,000 civil penalty for first violations, as of January 1, 2027. In addition, New York introduced a similar bill prohibiting certain food additives, including BVO.

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FDA Law Blog

NOVEMBER 16, 2021

In 2025, the Secretary would select no more than 10, 15 in 2026, 15 in 2027, and 20 in 2028 and subsequent years. There would also be a renegotiation process beginning in 2027 for selected drugs for which factors that the Secretary considered had changed. That’s a difficult pill to swallow.

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FDA Law Blog

MARCH 5, 2024

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. Opinion at 17. contradicts the plain text of the statute and therefore must be set aside.” see also 42 U.S.C.

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FDA Law Blog

AUGUST 23, 2023

A DHT is considered “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses.” External programs include FDA meetings with sponsors, drug development tool qualification, establishing guidance, public meetings, demonstration projects, and engagement with external organizations.

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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 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

CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027). CDRH will provide written feedback on requested topic(s) pertaining to the TAP device other than biocompatibility and sterility within 40 days of the request for 90% of requests for written feedback. See Program Website.

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FDA Law Blog

NOVEMBER 21, 2022

CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027). CDRH will provide written feedback on requested topic(s) pertaining to the TAP device other than biocompatibility and sterility within 40 days of the request for 90% of requests for written feedback. See Program Website.

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FDA Law Blog

JANUARY 29, 2025

Will he wait until the next PDUFA reauthorization in 2027 to instill additional changes at the agency? The Senate Finance Committee will hold the first day of hearings, which will then move over to the Health, Education, Labor and Pensions on Thursday. Kennedy may also face questions about what he thinks is corruption at FDA.

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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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FDA Law Blog

JUNE 27, 2022

A little-noticed section (13101) of the Bipartisan Safer Communities Act , signed by the President on Saturday, continues the pattern by extending the moratorium on the rebate rule one more year until January 1, 2027, this time to help pay costs of implementing the gun violence reduction measures in that legislation.

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Physician's Weekly

JUNE 25, 2025

The use of AI in making prior authorization decisions isn’t new — and it will probably continue to ramp up, with insurers pledging Monday to issue 80% of prior authorization decisions “in real-time” by 2027. “This is an opportunity for the industry to show itself.” Prior authorization isn’t going anywhere.

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