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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Broad Institute

AUGUST 7, 2023

A surprising new role for a major immune regulator By Tom Ulrich August 7, 2023 Breadcrumb Home A surprising new role for a major immune regulator By Anne Trafton, MIT News August 7, 2023 Credit: RCSB Protein Data Bank A model of the human STING protein.

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Vial

FEBRUARY 21, 2024

There is a strong demand for innovative products that are essential in monitoring, preventing, and treating diseases or disabilities. Clinical trials are needed to determine whether a medical device can produce sufficient proof of its efficacy. Medical devices have seen a significant increase in market demand for the past few years.

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

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Cytel

APRIL 5, 2024

Written by Sydney Ringold, Customer Success Manager, and Kevin Trimm, Chief Product Officer In an ever-changing clinical development environment, sponsors face many challenges when designing clinical trials. When designing trials, biostatisticians have a choice between two main tools: commercial software or open-source development.

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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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Olympian Clinical Research

FEBRUARY 13, 2024

When it comes to maintaining healthy, vibrant skin, the choice of skincare products plays a pivotal role. At Academic Alliance in Dermatology, we understand the importance of using products that not only care for your skin on the surface but also work effectively at a cellular level.

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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

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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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. There is a race in the field to overcome these challenges to enable the success of CGT products in Asia-Pacific.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 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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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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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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ProRelix Research

NOVEMBER 14, 2023

The growing impetus for the conduct of clinical trials outside the United States for products and medical devices intended to be used in the US include multiple reasons such as […] The post US FDA Foreign Clinical Trial Data Requirements appeared first on ProRelix Research.

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PPD

AUGUST 9, 2023

The increased adoption of decentralized clinical trial (DCT) designs has revolutionized how the industry approaches clinical studies. In short, for clinical trial design to truly benefit from the digital revolution, data flow, management and analysis are the next frontiers.

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Quanticate

JUNE 13, 2024

The life sciences industry is one of the most rigorously regulated sectors globally, prioritising patient safety during clinical trials and post-marketing phases. All trials must comply with country-specific regulations set by regulatory bodies.

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Advarra

OCTOBER 26, 2023

Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. Requirements for Transport of Investigational Products Accidents can happen. Some institutions require additional specific paperwork, so be sure to review internal policies prior to transport of the investigational products.

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PPD

NOVEMBER 7, 2023

Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” Strategies to Increase Diverse Populations in Dermatology Clinical Trials 1. ” Adding to this momentum, in December 2022 the U.S.

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). In particular, regulations in both the U.S.

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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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The Pharma Data

SEPTEMBER 1, 2020

Explore how emerging trends in clinical trial investigations are bringing patients closer to medicine making them more patient-centric. In addition, you agree to having your details passed onto the sponsor who may promote similar products and services related to your area of interest subject to their privacy policy.

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Advarra

NOVEMBER 17, 2022

Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children. Usually, when there aren’t data to support enrolling children in clinical trials, the risk threshold requires the prospect of direct clinical benefit. Why This Guidance Now? Pediatric studies are necessary.

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The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., The drug product is packaged and shipped as a solid powder.

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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. Earlier this year, FDA published the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development (DHT Framework). By Adrienne R.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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Advarra

OCTOBER 14, 2022

In the context of decentralized clinical trials (DCTs), we have seen an explosion of new devices and apps interacting with participants and collecting information throughout a trial, all with the participant never setting foot in a traditional clinical research site. What is this innovation?

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ProRelix Research

NOVEMBER 23, 2022

Biological products have unlocked the potential for the management of several diseases such as cancers and autoimmune diseases for which treatment with small molecule, chemically synthesized drug molecules remain suboptimal. […]. The post Biosimilar Clinical Trials and US FDA Guidance appeared first on ProRelix Research.

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The Pharma Data

JANUARY 4, 2021

Drug discovery and development for these drug products is often carried out by academic investigators rather than by biopharmaceutical or pharmaceutical companies, said Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research, in announcing the draft’s release. The draft is open for comment until March 5.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Advarra

SEPTEMBER 23, 2022

Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . Once an IND is in effect, a sponsor may ship the investigational product to the investigator(s) named in the IND application.

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The Pharma Data

JANUARY 25, 2021

Maypharm is focusing on outstanding pharmaceutical products to provide superior botulinum toxin product with an up-to-date technological advantage and elaborated advanced manufacturing quality system and sophisticated equipment to meet the GMP requirements of the Agency’s CGMP regulations.

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FDA Law Blog: Biosimilars

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. By Adrienne R.

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The Pharma Data

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. In the U.S.,

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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 ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. How does “potency” apply to cell and gene therapy (CGT) products?

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Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. These risks face fewer regulations but must meet certain standards to ensure ethical use. High Risk AI-powered Systems: Key Requirements The AI Act will likely consider many AI-based systems used in clinical trials today as “high risk.”

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