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2025 Marketing Regulations 
Fierce BioTech
OCTOBER 15, 2024
A Pharma Marketers' Roadmap to Data Privacy Compliance : Are You Ready for 2025? swheeler Tue, 10/15/2024 - 19:53 Thu, 11/21/2024 - 13:00 Resource Type Webinar Ben Chapman Duration 60 minutes Join for an insightful webinar on the evolving privacy landscape impacting pharma marketers in 2025.
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Perficient: Drug Development
NOVEMBER 15, 2024
Our experts are closely monitoring eight healthcare trends that are shaping industry leaders’ strategies in 2025. election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. And this year is especially interesting, as 2024’s U.S. billion by 2030.
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Perficient: Drug Development
NOVEMBER 15, 2024
Our experts are closely monitoring eight healthcare trends that are shaping industry leaders’ strategies in 2025. election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. And this year is especially interesting, as 2024’s U.S. billion by 2030.
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Agency IQ
JANUARY 12, 2024
To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. has done.
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Agency IQ
JULY 22, 2024
The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.
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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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BioPharma Drive: Drug Pricing
DECEMBER 19, 2023
A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.
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PPD
MAY 7, 2024
The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.
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thought leadership
MAY 7, 2024
Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health Technology Assessment Regulation (HTAR), which will take effect in January 2025.
Agency IQ
AUGUST 9, 2024
Commission proposes exemptions to UV-328 ban under POPs Regulation The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). UV-328 is used in a wide range of applications as a UV absorber and stabilizer.
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Agency IQ
JUNE 21, 2024
Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.
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PPD
APRIL 30, 2024
31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.
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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thought leadership
JUNE 4, 2024
Health technology developers (HTD) planning submission of a centralized Market Authorization Application (MAA) to the European Medicines Agency (EMA) should being preparing today for the implementation of the European Health Technology Assessment Regulation (HTAR).
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FDA Law Blog: Biosimilars
NOVEMBER 7, 2024
By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. If it does, the letter will also identify the device class, whether a premarket notification or premarket approval is required to market the device, and other pertinent information. Sometimes, though, the question of classification defies an easy answer.
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Agency IQ
NOVEMBER 10, 2023
The still-pending agreement seems likely to soon be adopted, which would trigger an application date of January 1, 2025. The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers.
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Agency IQ
JULY 8, 2024
What we expect European regulators to do in July 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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Agency IQ
MAY 31, 2024
What we expect European regulators to do in June 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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Agency IQ
JUNE 16, 2023
The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.
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Agency IQ
MAY 3, 2024
What we expect European regulators to do in May 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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Agency IQ
OCTOBER 27, 2023
What we expect European regulators to do in November 2023 In this new 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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Agency IQ
MARCH 29, 2024
What we expect European regulators to do in April 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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Agency IQ
AUGUST 4, 2023
This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. The European centralized marketing authorization procedure is no longer a valid medicines approval pathway for the U.K. member states.
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Agency IQ
DECEMBER 1, 2023
What we expect European regulators to do in December 2023 In this new 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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FDA Law Blog: Biosimilars
MARCH 21, 2024
As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.
62 Agency IQ
JUNE 7, 2024
Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.
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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.
62 Agency IQ
FEBRUARY 15, 2024
MHRA selects eight technologies to help it test its new innovative devices pathway The British regulator and its partners just released the list of products and companies chosen to participate in the pilot of its Innovative Device Access Pathway (IDAP). device regulations and the pilot for innovative products. Life Sciences Vision.
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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. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.
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The Pharma Data
NOVEMBER 4, 2020
5, 2020 /PRNewswire/ — Bactiguard presents updated financial targets for 2025 in connection with the company’s financial report for the third quarter of 2020. We now have a broader base and better market coverage in Europe , the Middle East , India , Southeast Asia and China. STOCKHOLM , Nov. Profitability. unchanged).
52 Agency IQ
MARCH 25, 2024
AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. Our new resource aims to help make this a little bit easier.
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The Pharma Data
SEPTEMBER 16, 2020
SLB linked to 2025 Patient Access Targets to increase patients reached in low- and middle-income countries (LMICs) with strategic innovative therapies by 200% and the Novartis Flagship Programs by 50%. Novartis is taking bold steps to increase patient reach in LMICs with its strategic innovative therapies by at least 200% by 2025.
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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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Agency IQ
AUGUST 23, 2024
AgencyIQ summarizes the noteworthy changes in the updates to several documents designed to help sponsors and other entities involved with clinical trials to transition to the Clinical Trials Information System (CTIS) on January 30, 2025. Per the CTR, all clinical trials are to be moved over to the CTIS by January 30, 2025.
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.
The Premier Consulting Blog
DECEMBER 14, 2022
Growth of the digital health market Digital health is a dynamic, growing market, with almost $38 billion of new capital invested in startups in this space in 2021. By 2025, funding for DTx is expected to reach $56 billion.
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Agency IQ
MARCH 7, 2024
flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season. For vaccines manufactured in the United States for foreign markets, CBER release is still required.
40 
Drug Target Review
JULY 1, 2024
SRP-001 targets the central nervous system (CNS) by producing N-arachidonoylaminophenol (AM404) in the midbrain’s periaqueductal grey (PAG) region, crucial for pain sensation and regulation. Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies?
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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. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. Final Guidance at 2.
104 
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.
Agency IQ
MAY 10, 2024
The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. Again, it emphasized a goal of reducing pesticide use by half, this time by 2025. The newest iteration of Ecophyto again seeks to cut pesticide use in half, though this time by 2030 rather than 2025.
40 Agency IQ
MAY 31, 2024
What we expect the EPA to do in June 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. This is what OIRA is currently reviewing.
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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. Most notably, the bill pushes the time for compliance with the 2021 statute from January 1, 2023, to January 1, 2025.
40 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. In FY 2025, continue to support products enrolled in previous fiscal years and expand to enroll up to 65 additional products in at least four OHTs (i.e.,
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