FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. By Steven J. Gonzalez & Lisa M. 21 CFR 820.20

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The Pharma Data

JULY 6, 2021

Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. Cash generated from operations is expected to exceed £10 billion by 2026. 2021-2026 outlook refers to the 5 years to 2026 with 2021 as the base year.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. CMS also intends to implement a compliance monitoring program through future regulations or guidance.

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The Pharma Data

JUNE 26, 2021

Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2026, except upon the occurrence of an early release event provided for under Article R. 3324-22 of the French Labour Code and authorized in the subscriber’s country.

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FDA Law Blog: Biosimilars

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 1] However, the focus of CLIA requirements is on laboratory processes, not specific assays.

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Perficient: Drug Development

NOVEMBER 21, 2024

The first compliance deadline of April 1, 2026, impacts the largest organizations. Under this ruling, banks, credit unions, credit card issuers, and other financial service providers must enhance consumer access to personal financial data. The ruling demands action from all non-depository firms (e.g.,

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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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The Pharma Data

DECEMBER 12, 2020

The success of the franchise is demonstrated by the effective transition of over 70% of PNH patients from Soliris to Ultomiris in less than two years of launch in its key markets, including the US, Japan and Germany , as well as the strong pipeline of additional indications for Ultomiris. Over 7,000 rare diseases are known today, and only c.5%

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The Pharma Data

NOVEMBER 11, 2020

market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfa pump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. In the U.S., and Canada. Source link.

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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.

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The Pharma Data

DECEMBER 16, 2020

market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfa pump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. In the U.S., and Canada. Source link.

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Agency IQ

AUGUST 4, 2023

Animal testing has been banned for cosmetic products since 2013 under the EU Cosmetics Regulation. Regulations are legislative instruments that apply across all member states as written. That ban on placing on the market extends to products using ingredients or combinations of ingredients that were subject to animal testing.

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Agency IQ

MAY 10, 2024

The new guidance maintains the agency’s existing definitions of remanufacturing and servicing, but adds a new section that provide a high level overview of the medical device regulations – primarily for those “less familiar.” Also this year, the FDA finalized its new rule on overhauling the medical device quality system regulations.

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Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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The Pharma Data

MAY 15, 2023

Sandoz is a pioneer and market leader in biosimilars and this partnership with Just – Evotec Biologics comes shortly after the company announced increased investments in its Holzkirchen site in Germany to create a core Biopharma Technical Development hub supporting future biosimilar growth.

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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.

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Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. OPEQ is organized into eight “Offices of Health Technology” (OHTs), which are structured by therapeutic area (e.g.,

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Agency IQ

JUNE 28, 2024

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. Used products and used product components are officially exempted from the regulations, as well as manufacturers that employ 25 or fewer people.

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Agency IQ

MAY 17, 2024

At that time, the FDA would no longer be able to award new vouchers to companies, unless the product already had rare pediatric disease designation, and obtained approval before October 1, 2026. focuses on marketing exclusivity periods granted to orphan drugs. DORIS MATSUI (D-Calif.) and GUS BILIRAKIS (R-Fla.),

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.

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The Pharma Data

OCTOBER 14, 2020

The global heart failure market represents a tremendous opportunity for Sequana Medical and we look forward to providing an update on the interim results from our RED DESERT study later this year.”. market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years.

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Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The study is planned to begin in 2026 and conclude in 2028.

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Perficient: Drug Development

SEPTEMBER 27, 2023

The overall EV market is quickly gaining momentum as governments worldwide push for a future with net-zero emissions and automakers rev up production to meet growing demand. In the first quarter of 2023, the total EV market share increased to 7.2% And demand is indeed growing. of total sales, representing a 50% jump year over year.

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Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2026 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Patient-Focused Drug Development FDA must issue or update guidance regarding the Agency’s collection of information from medical device facilities prior to inspection. Priority A List.

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Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

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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.,

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FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

As weve previously blogged, a PCCP is a mechanism established by Congress under the Food and Drug Omnibus Reform Act (FDORA) to streamline post-market changes to medical devices. If FDA agrees to the PCCP, such changes can be made without a supplemental marketing submission.

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Perficient: Drug Development

NOVEMBER 21, 2024

The first compliance deadline of April 1, 2026, impacts the largest organizations. Under this ruling, banks, credit unions, credit card issuers, and other financial service providers must enhance consumer access to personal financial data. The ruling demands action from all non-depository firms (e.g.,

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Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

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Perficient: Drug Development

MARCH 20, 2025

Balancing Innovation and Daily Operations Aileen brought a unique perspective from the highly regulated insurance and annuity space. Even in a regulated environment, were able to see progress that way. We hope to see you again at Adobe Summit 2026. So, I have our extended leadership team really drive new projects.

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FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs.

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