PPD

AUGUST 28, 2024

For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset. Many of these patients’ conditions are disabling.

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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

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

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LifeSciVC

APRIL 24, 2024

In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? To impart “gain-of-function” pharmacology, consider inducing or up-regulating expression (e.g., One example of such a genetics exercise is represented in Fig.

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H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When time is of the essence, like in a global pandemic, how do you scale trials internationally for success? Additionally, clinical trials are no longer confined to one country or region.

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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. This blog post explores key issues, opportunities and strategies for health technology developers (HTDs) navigating this changing landscape.

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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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DrugBank

APRIL 25, 2024

This tech can speed up everything from drug design to clinical trials by processing complex datasets more efficiently. Essentials include: High-Performance Computing Resources: These are critical for managing large datasets and running complex AI algorithms efficiently, which is a big deal for both drug discovery and clinical trials.

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Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

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H1 Blog

APRIL 5, 2023

Data networks are valuable to inform clinical trials with insights and analyses such as patient population selection criteria, site selection criteria, site performance evaluation criteria, Principal Investigator (PI) selection criteria, and incorporating population health efforts into informing trial selection.

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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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H1 Blog

JULY 19, 2023

Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics , regarding clinical trial design specific to oncology with considerations to support accelerated approval applications.

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FDA Law Blog: Drug Discovery

APRIL 23, 2023

Because an external control can involve the use of real-world data (“RWD”), the Draft Guidance notes that this guidance is being issued to satisfy, in part, requirements from the 21st Century Cures Act on the use of real-world evidence (“RWE”) in regulatory decision-making, similar to other recent efforts in this arena that we have blogged about.

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Advarra

FEBRUARY 4, 2025

At a busy research site, a clinical trial is ready to launch but its stuck in limbo over a single paragraph in the informed consent form (ICF). While the trial waits for approval, patients who are eager for a new treatment face delay. Language relating to the potential cost of participation. Age isnt the only factor to consider.

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Advarra

SEPTEMBER 23, 2022

In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. . There are three types of amendments specified in these regulations: . The sponsor of the investigation submits an IND to the FDA; . 21 CFR 312.40(a)

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Clinical Trials Trials FDA Regulations 52

Crucial Data Solutions

MAY 31, 2023

Clinical trials continue to move closer to patients. Improvements to data collection technologies and processes, a robust high-speed internet infrastructure, and pressure from regulators to make research more inclusive are converging, making exclusively site-based study designs increasingly rare. Luckily, there is one solution.

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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 ). But by their very nature, RWD/RWE will have some gaps compared to randomized controlled trials. By Jeffrey N. Congress has recognized the challenges with FDA’s acceptance of RWD and RWE.

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

The tools it uses to accomplish that mission include those designed to help regulated entities that want to follow best public health practices, like guidances, public notifications, and requests for information. This is another area in which FDA works with industry to try to ensure voluntary compliance from regulated entities.

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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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FDA Law Blog: Biosimilars

MARCH 22, 2023

We will continue to follow the developments, but for today’s blog, focus on what’s at stake—in short, massive amounts of damages and penalties. When an ambiguous law or regulation is presented to a court, it is the court’s job to decide what it means, no matter how ambiguous or inartful the provision may be.

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. In Wages and White Lion Investments (DBA Triton Distribution) v. FDA failed on each count.

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FDA Law Blog: Biosimilars

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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Clinical Trials Trials Regulations Treatment 59

Pharmaceutical Development Group

DECEMBER 19, 2021

Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits, or risks of a medical product derived from analysis of RWD.” “ Under FDA’s RWE Program, evidence from traditional clinical trials will not be considered RWE. Author Information William E. Spanogle, Ph.D.

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The Premier Consulting Blog

JUNE 26, 2023

In this blog post, we review the regulatory programs available to expedite treatments for rare disorders and serious diseases. 2 The regulations also reflect the agency’s recognition that patients and physicians might be willing to accept greater treatment-related risks for life-threatening or severely debilitating diseases.

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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

JULY 18, 2022

To protect human subjects in clinical research, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. What is an Electronic Master File (eTMF)? .

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

However, with this most recent approval, FDA did not leave the question of durability as something to be answered postapproval, which signals to us that this issue looms large in FDA’s preapproval regulation of gene therapies. We can see this evolution for requiring longer-term follow-up play out with this most recent approval of Hemgenix.

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Advarra

SEPTEMBER 20, 2023

Clinical trials receive a lot of oversight from regulatory agencies, as well as independent committees reviewing different aspects of the trial. While IRBs are also known as research ethics boards (REBs), ethics committees (ECs), or independent ethics committees (IECs), we will refer to this committee as an IRB in this blog.

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Clinical Trials Trials FDA Regulations 52

The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product.

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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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Advarra

NOVEMBER 10, 2022

This blog highlights some of the major proposed changes and how they may impact the clinical research community. . In addition to the harmonization goal, these additional elements help modernize the regulations with current scientific and participant expectations. . Again, this is similar to what HHS regulations currently permit.

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Advarra

AUGUST 31, 2022

This blog will explore how each of these works to support a successful development process and why their interconnectivity is important. Developing a regulatory pathway assessment (RPA) is a formal exercise for any new company or device to establish the way a regulator may accept the device in terms of risk-benefit. Intended use.

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Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. The short answer: No.

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Advarra

DECEMBER 15, 2022

As the research community continues to seek clinical trial efficiencies designed to bring therapies to patients faster, more governing bodies are pushing for single institutional review board (single IRB) review as one way to streamline efforts. This blog provides a beginner’s overview of single IRB review in the U.S.

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Clinical Trials Regulations FDA Trials 52

PerkinElmer

JUNE 23, 2020

The pharmaceutical industry is no exception with clinical trials are underway to develop a vaccine and identify potential therapeutics. However, management of the virus continues to bewilder the world’s finest researchers and clinicians… and our traditional standards of pharmaceutical regulation have necessitated adaptation.

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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. In March of this year, FDA convened the first public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review.

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