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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). 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. By Jeffrey N.

FDA

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Article EMA Thank You Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025

Agency IQ

JULY 22, 2024

Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025 The new EUDAMED roadmap includes updates accounting for the recent amendments to the European medical device and diagnostics regulations, which allow for a phased rollout of the different functional modules of the database.

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Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog: Biosimilars

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. In March of this year, FDA convened the first public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review.

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Article EMA Thank You Proposal for IVDR extension also impacts MDR, EUDAMED

Agency IQ

JANUARY 26, 2024

regulators considered the highest-risk IVD devices, and these and devices for self-test by the patient required Notified Body oversight. The IVDR originally gave stakeholders 5 years to comply with the regulation (May 26, 2022). The directive used a list-based system – List A and List B outlined what E.U. In-house tests (in the U.S.

Regulations

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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog: Biosimilars

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. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

FDA

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FDA’s LDT Proposal and Its Impact on Clinical and Regulatory Professionals

The Premier Consulting Blog

NOVEMBER 20, 2023

The FDA is proposing a change to its regulations to explicitly classify In Vitro Diagnostics (IVDs) as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), irrespective of the manufacturer being a laboratory that previously conducted business and was certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

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Article FDA Thank You Diagnostics landscape analysis: Key issues and a look ahead at 2024

Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S., In the E.U.,

FDA

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Q BioMed’s Uttroside-B Receives U.S. FDA Orphan Drug Designation in the Treatment of Liver Cancer

The Pharma Data

JANUARY 26, 2021

As an Orphan Drug, Uttroside-B may benefit from a seven-year market exclusively following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. billion by 2027. About Q BioMed Inc. Q BioMed Inc. .

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Analysis Life Sciences Thank You A deep dive into MDR and IVDR implementation: Where we are and where we’re going

Agency IQ

AUGUST 18, 2023

A deep dive into MDR and IVDR implementation: Where we are and where we’re going Late last summer, AgencyIQ took a close look at how the European Commission had been meeting its goals in implementing the medical device and IVD regulations (MDR and IVDR, respectively). regulators. reference laboratories. reference laboratories.

Science

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Analysis Life Sciences Thank You Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform

Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science

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Article FDA Thank You Top questions on FDA’s proposed LDT rule: Carve outs, capacity and quality systems

Agency IQ

NOVEMBER 3, 2023

BY LAURA DIANGELO, MPH | OCT 30, 2023 9:38 PM CDT FDA’s new proposed rule on the regulation of laboratory developed tests An incredibly quick background : Laboratory developed tests (LDTs) are considered a subset of in vitro diagnostics (IVDs). IVDs are regulated as medical devices in the U.S., Quick intro: QSR, QMSR.

FDA

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Article Periodic Thank You 3M PFAS settlement gains final court approval

Agency IQ

APRIL 8, 2024

This relatively low opt-out number means that most municipalities determined that the settlement is the best way to ensure payment from 3M for PFAS-related remediation, rather than gambling for years on the outcome of a high-stakes trial. billion pre-tax, followed by a gradual reduction in payments (excluding 2027, which will include $2.6

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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law Blog: Biosimilars

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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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA

FDA Science Biosimilars Clinical Trials

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

FDA

FDA Science Biosimilars Regulations

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. The size of the trials was comparable to those of new molecular entities—drugs that have never before been approved by the FDA.

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5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

BioPharma Drive: Drug Pricing

JULY 21, 2025

Published July 21, 2025 Ben Fidler Senior Editor Ned Pagliarulo Lead Editor post share post print email license Courtesy of Sarepta One month ago, a 51-year-old man treated in a clinical trial with an experimental gene therapy became dangerously sick. They’ve seen access for Elevidys restricted and clinical trials put on hold.

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PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

FEBRUARY 8, 2021

RE47,739 (‘739) by more than four years until March 5, 2027. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% Patent Term Extension (PTE) certificate for IBRANCE® (palbociclib).

Clinical Trials

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To Be Born in a Bag

Codon

OCTOBER 6, 2024

Results such as these have been so encouraging that in September of last year, the FDA began to review the idea of moving to human trials. Indeed, the stakes in the first real-world use of artificial wombs may be higher than in almost any clinical trial imaginable. ” Others have much more ambitious plans for the next five years.

FDA

FDA Hospitals Engineering Research

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

RE47,739 for Ibrance by more than four years until March 2027. Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial. In February 2021, Pfizer announced that the U.S. Patent and Trade Office issued a U.S.

Vaccine

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

Article EMA Thank You Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025

Trending Sources

Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

Article EMA Thank You Proposal for IVDR extension also impacts MDR, EUDAMED

No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA’s LDT Proposal and Its Impact on Clinical and Regulatory Professionals

Article FDA Thank You Diagnostics landscape analysis: Key issues and a look ahead at 2024

Q BioMed’s Uttroside-B Receives U.S. FDA Orphan Drug Designation in the Treatment of Liver Cancer

Analysis Life Sciences Thank You A deep dive into MDR and IVDR implementation: Where we are and where we’re going

Analysis Life Sciences Thank You Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform

Article FDA Thank You Top questions on FDA’s proposed LDT rule: Carve outs, capacity and quality systems

Article Periodic Thank You 3M PFAS settlement gains final court approval

Article EMA Thank You What we expect European regulators to do in August and September 2024

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

To Be Born in a Bag

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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