Drugs.com

MARCH 3, 2025

MONDAY, March 3, 2025 -- In a policy statement published today in the Federal Register, Robert F. Department of Health and Human Services, has rescinded the current policy of requiring new rules and regulations to. Kennedy Jr., secretary of the U.S.

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Regulations 246

Perficient: Drug Development

FEBRUARY 12, 2025

Payments Trend #1: AI-Driven Payment Innovations The landscape of payments and financial services in 2025 will be marked by groundbreaking innovations and user-centric designs powered by Generative AI (GenAI). The fintech industry, once celebrated for its agility and innovation, now faces a future shaped by heightened regulation.

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Compliance Regulations Production Government 52

Drugs.com

FEBRUARY 13, 2025

13, 2025 -- A legal loophole is allowing marijuana ads to slip past regulations and land right in front of kids on social media, a new report shows.Although the federal Controlled Substances Act prohibits advertising the sale or use. THURSDAY, Feb.

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Regulations 200

BioPharma Drive: Drug Pricing

JANUARY 23, 2025

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.

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Regulations FDA 143

Broad Institute

MARCH 12, 2025

New technology puts a spatial lens on CRISPR screening By Leah Eisenstadt March 12, 2025 Breadcrumb Home New technology puts a spatial lens on CRISPR screening Perturb-FISH reveals impacts of perturbations on gene expression and phenotype with single-cell, spatial resolution, allowing study of effects within and between cells.

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RNA Science Research Disease 99

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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Marketing Regulations Drugs 164

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

To this end, the December 2024 draft guidance and a companion guidance published January 7, 2025, Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway (the January 2025 draft guidance ) describe FDAs latest thinking on what it means to conduct a confirmatory trial with due diligence.

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FDA Trials Disease Drugs 105

Fierce BioTech

MARCH 25, 2025

How Japan and South Korea are Shaping the Next Era of Clinical Development Discover why Japan and South Korea are emerging as clinical trial powerhouses, offering cutting-edge infrastructure, streamlined regulations, and unique commercial advantages. CMIC Group Resource Type Whitepaper CMIC_ListingLogo_250x190.png

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Clinical Development Clinical Trials Regulations Trials 52

PPD

FEBRUARY 19, 2024

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities. Ongoing trials must transition to the EU CTR by Jan.

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Clinical Trials Regulations Trials Clinical Research 96

Drug Channels

MARCH 4, 2025

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: PBM Industry Update: Trends, Challenges, and What's Ahead This event will be broadcast live on Friday, April 4, 2025, from 12:00 p.m. This event is part of The Drug Channels 2025 Video Webinar Series.

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Pharmacy Specialty Pharmacies Marketing Drugs 94

FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. If a compliance or quality program exists only as bargaining chip to use with regulators, thats not a formula to instill good habits.

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Compliance Regulations FDA Government 66

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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Regulations Marketing 59

Fierce BioTech

FEBRUARY 12, 2025

Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement. Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement.

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Regulations Marketing Compliance Production 52

Fierce BioTech

JANUARY 23, 2025

What Youll Learn: How contract sales models can help you stay ahead, amid shifting trends + evolving regulations. On Demand Start Date Wed, 03/05/2025 - 13:00 End Date/Time Wed, 03/05/2025 - 13:00 Ways to use smart tech + data insights to supercharge your teams effectiveness.

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Government Regulations Marketing 52

Agency IQ

NOVEMBER 10, 2023

The European Commission has proposed a regulation to revise the fees regulation governing the cost of compensating the European Medicines Agency (EMA) for its regulatory activities, with the aim of streamlining the fee structure and increasing fees in line with the cost of services and inflation.

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Regulations Government 59

Fierce BioTech

OCTOBER 31, 2024

The tools developed function entirely post-translationally, enabling synergistic strategies with engineerable regulation across multiple levels of the central dogma. The tools developed function entirely post-translationally, enabling synergistic strategies with engineerable regulation across multiple levels of the central dogma.

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DNA Regulations 64

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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Compliance Marketing Regulations 52

Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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Drug Development Clinical Pharmacology Immune Response Drugs 52

H1 Blog

DECEMBER 11, 2024

In this edition, our CEO and co-founder, Ariel Katz, along with Regional VP of Trial Landscape, Ryan Brown, share their top predictions for 2025. Ryan Brown , Regional VP, Trial Landscape Global standards for diversity plans will emerge in 2025. Ariel Katz , CEO & Co-Founder AI will be used to combat rare diseases.

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Clinical Trials Trials Pharma Companies Treatment 52

FDA Law Blog: Biosimilars

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. On March 13, 2025, the Federal Circuit ventured into the world of reissued patents and PTE. (

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Pharmaceutical Companies FDA Production Regulations 59

FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. This is achieved through firsthand insights, real-world examples, and case studies from FDA-regulated products. And it is exactly that!

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FDA Clinical Trials Regulations Production 59

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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Regulations Production Engineering International 40

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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Regulations Pharmaceutical Companies International Pharmaceuticals 52

Agency IQ

JULY 22, 2024

BY COREY JASEPH, MS, RAC 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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Regulations 59

FDA Law Blog: Biosimilars

JULY 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda.

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Regulations FDA Drugs 52

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.

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Clinical Trials Trials Regulations Pharmaceutical Companies 52

Agency IQ

JANUARY 12, 2024

device regulation timelines 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. New roadmap sets out U.K.

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Regulations Government Compliance International 40

Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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Regulations International Production Government 40

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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Regulations Marketing Clinical Trials Trials 40

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.

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Pharmaceutical Companies International Regulations Pharmaceuticals 59

ACTO

DECEMBER 17, 2024

A survey of healthcare and life science companies found that 93% of these companies expect to increase their spend in 2025. The Foundational Pillars ACTO believes in implementing four foundational pillars that will ensure responsible AI solutions that address pharmas highly regulated parameters, while providing value.

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Government Compliance Pharmaceutical Companies Pharmaceuticals 52

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). This exemption is in accordance with Article 4(1)b of the POPs Regulation.

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Regulations Production International Marketing 40

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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Regulations Clinical Trials Production Trials 40

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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Regulations Production Compliance Pharmaceuticals 40

Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

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International Regulations Licensing Licensing 40

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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Regulations Pharmaceuticals Government Therapies 40

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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Regulations Pharmaceuticals Production Vaccine 40