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. Such cross-functional collaboration ensures consistent implementation from drug development through commercialization. The stakes for AI adoption in the pharmaceutical industry have never been higher.

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Perficient: Drug Development

OCTOBER 15, 2024

Lets talk about data governance in banking and financial services, one area I have loved working in and in various areas of it … where data isn’t just data, numbers aren’t just numbers … They’re sacred artifacts that need to be protected, documented, and, of course, regulated within an inch of their lives.

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Perficient: Drug Development

OCTOBER 1, 2024

However, rather than the same sign to be put online, the December 2023 rule established a new black and navy blue official digital sign shown below: Beginning on New Year’s Day 2025, banks will be required to display the FDIC official digital sign near the name of the bank on all bank websites and mobile applications.

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Conversations in Drug Development Trends

MAY 23, 2024

The CRO landscape is rapidly evolving with the recent implementation of the EU Clinical Trials Regulation No 536/2014 (EU-CTR) and the launch of the Clinical Trials Information System (CTIS). These designs allow for evaluating multiple drugs or treatments simultaneously, offering a more flexible and efficient approach to drug development.

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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.,

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Agency IQ

JULY 22, 2024

While the agency has been working to implement its rule, which has broad-reaching impacts for diagnostics and drug developers, other moves by the Supreme Court and legislators could impact the agency’s next steps. AgencyIQ provides a status update for regulated industry. diagnostic products are regulated as medical devices.

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Agency IQ

JULY 7, 2023

This study was developed to help establish a workable framework for using real-world evidence (RWE) for regulatory cases within the E.U., building off the EMA’s Strategy through 2025. Regulators have been investing in ways to understand better how RWE can be used and how RWD is generated.

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Regulations Research Production Government 40

Perficient: Drug Development

OCTOBER 7, 2024

Introduction A quick summary of the new official digital sign requirement of the FDIC is that effective January 1, 2025, this logo: must be replaced by this logo: For readers who missed part 1 of this series or want to reread the original blog can find it here. 12 CFR § 328.5(a).

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JULY 28, 2023

FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.” Industry wants its products reviewed quickly, efficiently and predictably. Without sufficient resources, the FDA is unable to do so.

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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. This study is planned to start in late 2024 and conclude in late 2025.

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Perficient: Drug Development

NOVEMBER 14, 2023

My son’s part of Generation Alpha, a cohort that includes children born between 2010 and 2025. And games like Mightier combine biofeedback with emotional regulation to teach kids how to control their anger and anxiety. That’s where you as a healthcare marketer come in. The oldest of the Gen Alpha kids are only 13.

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Agency IQ

JULY 22, 2024

The regulators were off to a slow start, with just three total approvals in the first two months of 2024. Assuming that the comment period is not extended, and FDA meets its statutory timeline to finalize the guidance within nine months of the closing of the comment period, the guidance could theoretically be put into force by late 2025.

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Agency IQ

JUNE 21, 2024

Modeled on the Operation Warp Speed vaccine development communications approach, the pilot aims to test out a rapid communications approach for accelerating rare disease drug development. Marks also conceded that certain gene therapies might also have a different acceptable approach for confirmatory studies.

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Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis. Although the E.U.

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) 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.

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Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Discover how drug developers, researchers, and regulators are ensuring this happens. Tags Clinical Trials Weight 15

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FDA Law Blog: Drug Discovery

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. Another question is the impact on rare disease drug development, where broader populations are small and there may be limited knowledge about differential impacts of disease. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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Agency IQ

JUNE 28, 2024

In response, regulators reiterated its importance and prioritization without committing to a specific time frame for publication. That statutory requirement for a DAP is based on the applicability of the Investigational Device Regulations (IDE). ANNA ESHOO (D-Calif.) at a Friends of Cancer Research event in February 2024.

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thought leadership

JANUARY 21, 2025

Gaining a Competitive Edge: 2024's European Pharma Regulatory Review & Trends to Look for in 2025 and Beyond As the pharmaceutical landscape in Europe evolves rapidly, regulatory frameworks are adapted to accommodate the increasing complexity of drug development, particularly for innovative products such as biologics, advanced therapies, and digital (..)

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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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Regulations Compliance Production Nurses 64

Perficient: Drug Development

FEBRUARY 27, 2025

As we progress through 2025, the banking industry is set for substantial transformation driven by several key trends. In 2025, banks will face a more complex regulatory environment, with new rules focused on data privacy, cybersecurity, and sustainability.

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Compliance Production Regulations Marketing 52

Perficient: Drug Development

NOVEMBER 21, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Regulations Government Compliance 52

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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PPD

JANUARY 21, 2025

As 2025 kicks off, the biopharma and biotech industries find themselves at a pivotal juncture, navigating an era of rapid transformation marked by new technological advancements, evolving regulations and shifting industry priorities. However, amid this progress, the complexities of drug development have never been more apparent.

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Clinical Trials Trials Clinical Research Drug Development 52

Perficient: Drug Development

JANUARY 17, 2025

In 2025, the medical device industry trends are not just shaping the futurethey’re redefining the present. Explore the key trends shaping 2025, uncovering data-driven insights and actionable strategies to seize opportunities and maintain a competitive edge in this rapidly evolving industry.

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Perficient: Drug Development

FEBRUARY 24, 2025

Driven by factors ranging from generational wealth transfer to technological advancements, Perficients Principal in Wealth and Asset Management, Gerardo Montemayor , provides valuable insights into the wealth management trends set to transform the industry in 2025.

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Drug Target Review

MARCH 13, 2025

Planning the journey from data to deliverables The future of AI-enabled drug development benefits from the continued advancement of multimodality and clinical genomics, with a focus on integration, efficiency and personalisation to transform both care and R&D.

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Drug Development Science Clinical Trials FDA 59

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

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Clinical Trials Trials Clinical Research Government 88

Drug Target Review

APRIL 1, 2025

Co-founder and CEO Dr Dan Williams brings over 20 years of experience in biochemistry and drug development, with a strong background in research and clinical trials. His expertise has positioned SynaptixBio to advance its drug candidates toward clinical trials. It also received two grants from Innovate UK, totalling 2.5

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FDA Law Blog: Biosimilars

JANUARY 16, 2025

Hyman, Phelps & McNamara PC, (HPM), which will mark its 45thAnniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. She already has broad-based exposure to a variety of FDA regulated products. Richardson has been promoted to Director.

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Drug Channels

FEBRUARY 3, 2025

Informa Connect's Access USA March 18-20, 2025, Pre-Event Workshops on March 17 Drug Channels readers save 10%* on their registration with code 25AUSA10 Three events. Rare Disease Summit Download Agenda While the industry has seen heightened focus surrounding rare drug development, weve only scratched the surface.

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Specialty Pharmacies Pharmacy Government Disease 52

Drug Target Review

NOVEMBER 27, 2024

Introduction Biomarkers are becoming increasingly essential in drug development and clinical practice, driving the need for more precise validation methods. 2 The biomarker development pipeline involves multiple stages, including discovery, analytical validation, clinical validation and regulatory qualification. only about 0.1

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LifeSciVC

FEBRUARY 18, 2025

At the risk of diving into the scientific weeds, what follows is an attempt to highlight the importance of these findings and their implications for drug development in muscular dystrophy. As such, the DGC and its underlying biophysical and mechanical properties have long been of high interest for academics and drug developers alike.

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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. She said, Trying to carve that out and get people to still think innovatively can be challenging because theres so much day to day.

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