FDA lifts pause on Novavax flu vaccine trials
BioPharma Drive: Drug Pricing
NOVEMBER 11, 2024
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.
FDA Guidance on Advancement of Decentralized Clinical Trials
ProRelix Research
AUGUST 3, 2023
Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects in trials has […] The post FDA Guidance on Advancement of Decentralized Clinical Trials appeared first on ProRelix Research.
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Clinical Trials and Human Subject Protection as per US FDA
ProRelix Research
NOVEMBER 5, 2024
Clinical trials are necessary in advancing medical research and health care options by allowing new treatments to be introduced in the market through safety and efficacy testing in humans. Successful […] The post Clinical Trials and Human Subject Protection as per US FDA appeared first on ProRelix Research.
FDA puts Novavax flu vaccine trials on hold
BioPharma Drive: Drug Pricing
OCTOBER 16, 2024
The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.
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Why Including Patients in FDA Engagement Will Benefit Your Trial
Conversations in Drug Development Trends
AUGUST 23, 2023
Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. Her fellow panelists represented a diverse group of stakeholders across clinical research, including patient advocates, sponsors, sites, and the FDA itself.
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FDA lifts hold on PTC Huntington’s disease trial
BioPharma Drive: Drug Pricing
JUNE 20, 2024
The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.
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Accelerated Approval and Confirmatory Trials: Timing is Everything
The Premier Consulting Blog
OCTOBER 21, 2024
The FDA defines a serious condition as “a disease or condition associated with morbidity that has a substantial impact on day-to-day functioning.” Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.
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US FDA Foreign Clinical Trial Data Requirements
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.
Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management
ProRelix Research
DECEMBER 28, 2023
Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.
Clinical trial phases: What’s the difference?
Antidote
SEPTEMBER 25, 2023
Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed.
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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub
FDA Law Blog: Drug Discovery
JULY 17, 2024
Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).
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FDA Moves Beyond COVID-19, But Impacts on COVID-19 Era Clinical Trials Remain
FDA Law Blog: Drug Discovery
OCTOBER 11, 2023
Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” By James E. Valentine & Charles D.
FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns
BioPharma Drive: Drug Pricing
JUNE 4, 2024
A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.
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Biosimilar Clinical Trials and US FDA Guidance
ProRelix Research
NOVEMBER 23, 2022
The post Biosimilar Clinical Trials and US FDA Guidance appeared first on ProRelix Research. 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. […].
What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers
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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Emerging Trends in Clinical Trial Design
PPD
AUGUST 16, 2023
The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinical trial (DCT) models. However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs.
Verve gets FDA green light to run base editing study in US
BioPharma Drive: Drug Pricing
OCTOBER 23, 2023
The trial, which is ongoing in the U.K. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease. and New Zealand, has been on hold in the U.S.
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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials
FDA Law Blog: Drug Discovery
MARCH 7, 2024
Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.
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Food and Dietary Supplements Clinical Trials Regulations in USA
ProRelix Research
JUNE 27, 2024
In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […] The post Food and Dietary Supplements Clinical Trials Regulations in USA appeared first on ProRelix Research.
Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies
Conversations in Drug Development Trends
AUGUST 9, 2024
Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.
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FDA panel backs full approval for Eisai, Biogen Alzheimer’s drug
BioPharma Drive: Drug Pricing
JUNE 9, 2023
In a 6-0 vote, a group of independent advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.
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Importance of Patient-Reported Outcomes in Clinical Trials
Vial
JUNE 12, 2024
PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. Food and Drug Administration (FDA) increasingly look to patients to understand how they describe their health status. What are PROs in clinical trials?
Acceptance of foreign clinical trials data by US FDA
ProRelix Research
AUGUST 12, 2021
Acceptance of foreign clinical trials data by US FDA Foreign Clinical Trials (FCTs) Prior to the 1962 Kefauver-Harrison Amendments, it was uncommon for a Sponsor to submit FCTs data. The post Acceptance of foreign clinical trials data by US FDA appeared first on ProRelix Research. In […].
Meet C3TI, FDA’s new clinical trial innovation hub
Agency IQ
APRIL 19, 2024
BY LAURA DIANGELO, MPH 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). Fill out the form to read the full article.
7 Clinical trial advertising sample ideas
Antidote
MAY 30, 2023
To successfully advertise a clinical trial , it is important to create materials that engage patients and adhere to the strict guidelines of the Food and Drug Administration (FDA) in equal measure.
FDA Poised to Make Impact on Underrepresented Populations in Clinical Studies
H1 Blog
JULY 30, 2024
Diversity Action Plans (DAPs) aim to improve data that the FDA receives by increasing the clinical enrollment of historically underrepresented participants. The recent draft by the FDA introduces additional guidelines for Diversity Action Plans aimed at improving diversity in clinical research.
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FDA Returns Disappointing News for ALS Stem Cell Therapy
PLOS: DNA Science
OCTOBER 19, 2023
Last week DNA Science covered a setback in a clinical trial of a gene therapy for Duchenne muscular dystrophy (DMD). Also recently, FDA’s Cellular, Tissue, and Gene Therapies Advisory Committe turned down a stem cell treatment for amyotrophic lateral sclerosis, aka ALS, Lou Gehrig’s disease, or motor neuron disease.
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Human factor clinical trial recruitment strategies
Antidote
JULY 9, 2024
Though clinical trials are often discussed in the context of medications and therapies, the devices that administer these medications must also be approved by the FDA before they can be released to market.
ADC developed by Daiichi, Merck outperforms chemo in lung cancer trial
BioPharma Drive: Drug Pricing
SEPTEMBER 17, 2024
The FDA previously rejected patritumab deruxtecan over manufacturing issues. Tuesday's study data should boost the companies' case, however.
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How to Navigate Researching Targeted Therapies in Pediatric Oncology Clinical Trials
Fierce BioTech
SEPTEMBER 20, 2024
1 2 The diagnosis of cancer in children may be delayed due to the non-specific nature of t | Navigate current legislation and FDA guidance for pediatric oncology clinical trials with expert guidance from WCG. Although childhood cancer is rare, it is the leading cause of disease related death in children.1
Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)
FDA Law Blog: Biosimilars
NOVEMBER 6, 2023
Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. Significantly, FDA agrees that the RIEs may be conducted in lieu of an inspection. We should explain what RIEs are.
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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials
FDA Law Blog: Drug Discovery
MAY 4, 2023
Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. By McKenzie E.
How to Prioritize Pediatric Populations in NASH Trials
PPD
JUNE 7, 2023
Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations. Hispanic: 11.8%
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Shifting Paradigms in PAH Clinical Trials: 7 Key Takeaways for Success
PPD
AUGUST 5, 2024
Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.
FDA Launching New Advisory Committee on Digital Health
Eye on FDA
OCTOBER 12, 2023
FDA announced this week the formation of a new advisory committee – the Digital Health Advisory Committee – for the purpose of providing the agency with advice on matters related to digital health technologies (DHT). FDA does not form new advisory committees all that often, making it a notable development in more than one respect.
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FDA Guidance on the Design and Conduct of Externally Controlled Trials — What to Watch
Cytel
FEBRUARY 14, 2023
FDA has recently provided specific guidance [i] on the design and conduct of trials incorporating an external control group, sometimes known as a synthetic control arm.
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Cognitive and Pharmacodynamic Testing in CNS First-In-Human Trials
Alta Sciences
JULY 22, 2024
WATCH THE VIDEO You may also be interested in these resources: Webpage: CNS Drug Development Solutions Webinars: Inside the Pharmacodynamic Toolbox A Review of the FDA's Psychedelic Clinical Research Guidances Image Social_Media_Webinar_CNS_Active_Compounds_v2_04.jpg jpg Tags Clinical Trials Weight 1
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Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024
Agency IQ
JULY 22, 2024
BY AMANDA CONTI In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Halozyme drops Evotec buyout bid; Patient dies in Neurogene trial
BioPharma Drive: Drug Pricing
NOVEMBER 22, 2024
Elsewhere, Argenx has another blockbuster target in sight and an FDA veteran plans retirement. Evotec appears to have rebuffed Halozyme’s $2.1 billion acquisition attempt.
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AdComms – Is FDA Getting Less Advice?
Eye on FDA
AUGUST 4, 2021
As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product approvals. There are 31 advisory committees on matters ranging from food to medical devices to pediatric care.
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Alarm as FDA fast-tracks first antipsychotic drug for agitation in dementia
SCIENMAG: Medicine & Health
AUGUST 17, 2023
In trials, the antipsychotic drug brexpiprazole (Rexulti) failed to provide a clinically meaningful benefit and increased the risk of death. Yet the US Food and Drug Administration (FDA) has fast tracked its approval, making Rexulti the first antipsychotic for treating agitation in elderly patients with dementia.
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GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program
FDA Law Blog: Biosimilars
MARCH 29, 2024
Richardson — While Covid is in the rear view for most of us, FDA has had a tough time shaking off the effects of the pandemic on its inspection output. In March 2020 , FDA temporarily postponed all foreign and domestic and routine surveillance facility inspections. Inspections went down—way down—during the pandemic.
Apellis plans FDA filing after drug success in kidney trial
BioPharma Drive: Drug Pricing
AUGUST 8, 2024
Analysts at Evercore ISI called pegcetacoplan’s data in two kidney conditions a “left-field hit” that compare favorably to results for a Novartis treatment.
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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development
FDA Law Blog: Drug Discovery
NOVEMBER 10, 2024
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
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