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By Sarah Wicks — On May 21, 2024, the EveryLife Foundation for Rare Diseases (ELF) will host a Scientific Workshop at the National Press Club in Washington, D.C. aimed at identifying and characterizing the challenges in developing therapies for ultra-rare diseases and conditions that affect exceedingly small populations.
BY CHELSEY MCINTYRE, PHARMD , KARI OAKES In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drugdevelopment activities.
.” When it comes to personalization, all too often organizations employ tactics alone, despite a ton of effort being fed into strategic initiatives including customer journey mapping, persona development and user research. Interested in learning more? Reach out to me on LinkedIn , Twitter or fill out our contact form.
Thats where independent research from trusted industry analysts comes inhelping businesses identify top-performing partners that drive real results. Were excited to share that Perficient was recently recognized by a leading global technology research and advisory firm as a standout Salesforce ecosystem partner in the U.S.
By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC Patients and their care partners are at the center of our work in the life sciences industry – but at what point during the drugdevelopment process should companies start to engage these key stakeholders?
An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.
Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drugdevelopment activities.
As the FDA has previously acknowledged : “Many complex drug products did not exist” when the Hatch-Waxman Amendments was first passed into law. “As As drugs have increased in complexity in recent years, the scientific and regulatory roadmaps for drugdevelopment and approval may not be as well-established for more complex generics.”
FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.
The organization works directly with local communities, schools, and families to understand their needs and provide tailored support, whether it’s through after-school programs or weekend workshops. S tudents who have participated in Digi-Bridge’s programming report higher interest, confidence and competence in STEAM disciplines.
And being the basketball geek that I am, I did research to find out what the Timberwolves have done differently this season compared to other seasons that have helped them vault up to the top of the standings through the first month and a half of play. Competition: Perficient has created Now/New/Next to map the competitive landscape.
Additionally, the FDA’s Center for Drug Evaluation and Research (CDER) released a discussion paper this year to facilitate early feedback from stakeholders outside the Agency to consider when developing a future AI/ML regulatory framework.
The 2023 KAND Conference webpage has information related to: – registration link, hotel room link, KOALA participatio n, and agenda topics The KAND Conference will bring together patients, family members, researchers, clinicians, treatment developers, and friends of the KIF1A.ORG community. LET’S HELP THEM FLY!
Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC). By Holly N.
Title Type Comments Close Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance Draft Guidance August 5 Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research (..)
For example, in March 2023, FDA issued a Framework for the Use of Digital Health Technologies in Drug and Biological Product Development , which noted that FDA would publish guidance on the use of DHTs in both traditional and decentralized clinical trials.
Our work involves strategic and digital transformation topics ranging from technology innovation, data monetization, capabilities assessments, platform selections, AI, and analytical workshops. This year, we launched our EV research project that dove deep into insights straight from automotive customers.
Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation. 264) and the regulations in 21 CFR part 1271(361 HCT/Ps) are not regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
When we conducted our electric vehicle customer journey research last year, we confirmed a commonly held belief in the United States: most people aren’t happy with their dealership experiences, specifically as it relates to aggressive sales tactics.
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.
By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drugdevelopment A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The road to research on psychedelic products is paved with obstacles.
Today, the FDA unveiled a contract notice that explains the process for how it will develop that report, obtain public input, and deliver the report’s final recommendations. a disease or condition is defined as rare by the Orphan Drug Act (ODA) if it affects fewer than 200,000 people. In the U.S.,
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 drugdevelopment of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis.
Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drugdevelopment has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.
Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)
Title Type Comments Close Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act Guidance June 5 Patient Preference Information—Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in (..)
These include pre-amendment devices, cleared devices used on label, certain diagnostic devices, custom devices, veterinary use devices, devices for research with laboratory animals, and certain devices undergoing consumer preference testing or modification testing.
Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: DevelopingDrugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)
Regulatory context FDA held a workshop in December 2019 to discuss development of substance use disorder therapies. The goals of the workshop were to examine trends in stimulant abuse, discuss drugdevelopment for treatments, and gather stakeholder knowledge to develop new ideas for advancing development in this area.
In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. A year later, a similar workshop was conducted that included biologics and nonclinical models for efficacy, as well as modeling and simulation for dose-finding and dose optimization trials design.
FDA intends to award a sole source award to Eastern Research Group, Inc. In 2020, the agency awarded a contract to “establish a COVID-19 Sub-Registry to collect data on the safety of drug products used for the prevention or treatment of COVID-19 infection.” modernization efforts.
Leaders at FDA share highlights and updates for drugs and biologics at RAPS Convergence Top officials from FDA’s Centers for drugs and biologics—including Center for Biologics Evaluation and Research (CBER) Director Peter Marks—provided high-level updates at RAPS Convergence 2023 this week.
Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation. 264) and the regulations in 21 CFR part 1271(361 HCT/Ps) are not regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The European Commission also implemented its Mission on Cancer , which aims to further cancer research and innovation through funding in the same areas as the cancer plan. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.
Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)
Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in December and January FDA comment periods are typically open for 30-60 days, unless they are extended.
The documents describe all the guidance documents that are under development and that may be published in a given year. But there are some potential hints, such as an upcoming Friends of Cancer Research event at which several of FDA’s top officials will be speaking on the “implementation of diversity plans.”
Identifying a safe and effective dose for registrational trials is one of the most critical and complex aspects of early-stage drugdevelopment for rare diseases. Traditionally, early drugdevelopment focuses on ensuring the safety of clinical doses, with regulatory authorities prioritizing patient protection.
Offers fellowship programs and workshops, on-demand learning, and lecture series. Rare Cancers Program An initiative for development of new products to treat rare cancers Leverage multiple OCE projects and initiatives that address the challenges of developing new treatments for cancers that affect a small number of patients.
After earning my undergraduate degree from Connecticut College, followed by a PhD in organic chemistry from the University of Michigan, I landed a position as a researcher at a large biopharmaceutical company. The future of CMC lies in embracing more agile, science-driven approaches to drugdevelopment and manufacturing.
This transformation might involve establishing paid consulting opportunities for community experts, creating accessible design workshops in underserved neighborhoods, or forming equitable partnerships where decision-making authority is genuinely shared.
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