Minnesota Academy of Family Physicians

MARCH 13, 2025

Key Changes: It implements a base year payment rate structure effective January 1, 2026, which will set specific payment rates for various levels of care, including outpatient and residential treatment services, and mandates annual adjustments based on the Medicare Economic Index, beginning January 1, 2027.

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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. “Artificial intelligence should help this tremendously,” Rep. Gregory Murphy (R-N.C.),

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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. However, certain specifics are excluded from disclosure, including the sponsor’s name, product name/molecular structure, a complete description of study eligibility criteria, and patient-level data.

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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. By McKenzie E. Cato & Deborah L. We look forward to the roll-out of this new process, but it will be some time until we see it in action.

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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.

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FDA Law Blog

JUNE 8, 2023

FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition to in-person attendees).

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California Academy of Family Physicians (CAFP)

MAY 14, 2025

Imposes New (State-Only) Medi-Cal Premiums for Undocumented Adults – Implements $100 monthly premiums for undocumented adults aged 19 and older, effective January 1, 2027.

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The Medical Futurist

MAY 18, 2025

By 2027, global surgical robotics sales are expected to reach $14.8 The waiting lists can be long depending on available manpower and resources. Thus, surgical robots are the prodigies of surgery. According to market analysis, the industry is about to boom.

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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

SEPTEMBER 16, 2024

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

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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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ABIM

JUNE 12, 2025

The Specialty Board discussed strategies for recruiting Item-Writers and broader engagement with the geriatric medicine community and will work with ABIM staff to explore possibilities for in-person events or engagements at upcoming society national meetings in 2026 and 2027.

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FDA Law Blog

OCTOBER 12, 2023

Priority is given to Suitability Petitions that could mitigate or resolve a drug shortage; address a public health emergency declared by HHS; mitigate waste by way of new strengths for parenteral products; or subject to special review under the President’s Emergency Plan for Aids Relief.

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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.

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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.”

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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).

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FDA Law Blog

MARCH 5, 2024

To the extent that AstraZeneca alleged that CMS would cause it this type of harm in 2027, the court found that allegation to be too speculative. Because the alleged harm arises from the Act, not from the Guidance, the court found that AstraZeneca did not meet the causation or redressability elements of standing under this argument.

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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 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

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.

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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.

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GeriPal

APRIL 3, 2025

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. Nancy 47:33 And I sort of probably are going to have a brainstorm after. I honestly thought probably not for 2026 because it’s virtual.

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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? Kennedy has been critical of FDAs reliance on user fees to fund its mission. Will Kennedy try to overturn the user fee system thats been in place since 1992?

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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.

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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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