This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
The Tamil Nadu government has appointed the incumbent controlling authority (CA) of the drugs control administration, M N Sridhar, as state licensing and controlling authority (SLA and CA) for the department of drugs control from June 18 onwards.
The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers (..)
Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)
BioPharma Dive interviewed our Christine Moore on how to conduct psychedelic clinicalresearch. With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinicalresearch in this high-velocity area. These trials are often someone’s last hope,” Moore said.
The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.
Monitoring patient safety during a clinicaltrial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship between sponsors, sites, researchers, and everyone involved in the clinicaltrial phases.
Have you been tasked to develop a clinicaltrial budget? Well, you’re in luck because I’m going to share everything you need to know about clinicaltrial costs. Clinicaltrial budgets are often put together in haste. Developing a clinicaltrial budget can be a confusing exercise for sponsors and CROs.
The landscape of clinicaltrial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinicaltrials.
Lecanemab, the product of Phase IIb clinicalresearch completed by BioArctic and collaborator Eisai, is one therapy making strides this year for Alzheimer’s disease. Lecanemab , the product of Phase IIb clinicalresearch completed by BioArctic and collaborator Eisai, is one such therapy making strides this year.
The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.
A unified licensing authority titled as Indian Drug Regulatory Authority (IDRA) will garner the much needed recognition globally like US FDA or EMA, said Dr BR Jagashetty, former National […] India must now move towards looking to merge its Central and state enforcement wings and form a single authority.
Even as the Centre has listed the New Drugs, Medical Devices and Cosmetics Bill, 2023 to be tabled in Parliament during the current session, industry members are apprehensive that the new bill may mean centralisation of licensing and other powers to the Central drug regulatory authority and it may also have provisions which may harm […]
The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this […] (..)
With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.
The point of contention, they pinpoint, is that if any retailer and manufacturer fails to display the license in a prominent place and is not conspicuous to the public, it amounts to violation of the […]
The Central Drugs Standard Control Organisation (CDSCO) has re-issued the list of fixed dose combinations (FDCs), declared as rational by the Prof Kokate Committee earlier and was released in February in connection with their new drug status and the procedure to be followed by the applicants when approaching the state licensing authority, with some (..)
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 clinicaltrials.
The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]
The medical devices industry has urged the Centre to ensure obligation on the part of the buyer or users to purchase or use only those medical devices with required licenses and certifications under the New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, the draft of which has been circulated by the Union Health Ministry […].
This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinicalresearch teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”
As the research and medical community learns more about population variances in disease outcomes, whether as a result of regional genetic profiles, socioeconomic factors, or environmental inputs, it’s become necessary to ensure that clinicalresearchtrials include broad swaths of global participants.
Avoiding “Customs Chaos” in ClinicalTrials Means Working Closely with Your Importer of Record Many global clinicaltrial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinicaltrials.
Avoiding “Customs Chaos” in ClinicalTrials Means Working Closely with Your Importer of Record Many global clinicaltrial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinicaltrials.
The US-based company was founded in 2019 and is on a mission to bring the practice of pharmacy into clinicalresearch. He explores how COVID-19 has disrupted healthcare delivery and why virtual and decentralised trials could help increase patient access.
Whether you consider your program design to be virtual, remote or a hybrid of on-site and digital, decentralization of clinicalresearch provides the opportunity to reach a more diverse patient population and reduce the burdens of time and travel associated with traditional research models.
Even as a teen in Egypt, Amira Nada was drawn to the idea of clinicalresearch and how it could help people live healthier, richer lives. She decided to focus on patient recruitment to promote diversity in clinicaltrial populations. Through it all, her commitment to and belief in clinicalresearch never wavered.
Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. The post The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment appeared first on Worldwide ClinicalTrials. In June 2023, the U.S.
In this article, we will explore the significant value derived from conducting clinicaltrials sponsored by pharmaceutical companies for both physicians and hospital systems, with a specific focus on cancer care, and address potential counterarguments.
Decentralized clinicaltrial (DCT) elements enabled clinicalresearch to continue during the pandemic, when physical attendance at healthcare facilities was often impossible. Author: Jill Dawson The post Decentralized ClinicalTrial Models: Are They Here to Stay? DCT Models: Are They Here to Stay?
These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinicaltrial sites run by a third-party clinicaltrial site operator.
The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinicaltrials. Learn more Read more about Decentralized ClinicalTrials. DCTs can make things easier for patients and the research more efficient.
A common set of standards for randomised clinicaltrials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. Many guidelines focus narrowly on clinicaltrials that are intended to generate data for regulatory submission to support a new drug license.
AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinicaltrial of the antibody, with clinical development beginning in the US and expanding into Europe.
AstraZeneca is playing catch up with Eli Lilly and Regeneron with its antibody therapy for COVID-19, but aims to narrow the gap with the help of decentralised clinicaltrial specialist Care Access Research. The two antibodies were discovered by Vanderbilt University Medical Center and licensed to AZ in June 2020.
As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. Kaiser began Phase III trials of the vaccine at the end of July.
The ARCADIA trials reinforce nemolizumab’s potential as a transformative treatment for atopic dermatitis, offering new hope to patients seeking relief from this burdensome condition. The US Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for review, with a decision expected by the end of this year.
Before that, he’d spent 36 years in primary care, treating patients skewed toward the age group most at risk of Alzheimer’s, and it was this experience that, in part, encouraged him to cross over into clinicalresearch. “It The importance of clinicaltrials That hope is a motivator for many clinicaltrial participants.
Electronic Data Capture (EDC) has revolutionized clinicalresearch and pharmaceutical drug development. Direct costs include purchasing or licensing the EDC software, hardware acquisition (servers, devices), and system installation. However, adopting this system requires a significant financial commitment.
I was lost in my head thinking about how he may never get his driver’s license, attend his high school prom, or even graduate from kindergarten. Considering ClinicalTrials. When it became clear that Kai’s chemo plan was not helping, we turned to clinicaltrials.
A regulatory binder is essential for managing clinicaltrial 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.
PMRs/PMCs are studies or clinicaltrials that are conducted by the applicant after the Food and Drug Administration (FDA) has approved or licensed a product for marketing. These studies or clinicaltrials can be required either by regulation or statute (PMR), or by a written agreement, between FDA and the applicant (PMC). .
The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Blenrep in combinations with BVd and pomalidomide plus dexamethasone (BPd), with a decision expected by July 2025. A day before GSKs announcement, Johnson & Johnson also released two promising clinicaltrial results.
The common challenge is undertaking lengthy and capital-intensive phase II/III clinicaltrials. For example, if a company is carrying out clinicaltrials, then a clinicalresearch organisation is needed to run them. Companies have struggled to access intermediate capital.
While these NPDT products do not require FDA clearance, they must substantiate their claims with rigorous, clinicalresearch. These products require clinicaltrials to demonstrate their safety and efficacy before they can be prescribed by a licensed healthcare professional.
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content