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 (..)
The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the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.
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 (..)
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 […].
The US-based company was founded in 2019 and is on a mission to bring the practice of pharmacy into clinicalresearch. The post Pharmacy and clinicalresearch: the pharmaphorum podcast appeared first on.
It is very important to list past research experience which can help the PI stand out as qualified for specific indications. In addition to listing PI experience, it may also help to list the NPI number and medical license number for future reference and verification.
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 will conduct clinical development of ABBV-47D11, and if successful, will manufacture and market the product worldwide.
Swiss biotech company Stalicla has signed a licensing deal with Evgen Pharma for the latter’s lead asset, SFX-01, in neurodevelopmental disorders and schizophrenia. It is claimed to be the only grade of sulforaphane which is suitable for clinicalresearch and will eventually be approved as a medicine. Evgen will receive $160.5m
This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinicalresearch teams. Selected extracts from Everest Group’s PEAK Matrix® reports do not necessarily provide the full context of our research and analysis.
According to the company’s website, the biotech is undertaking research to decide on the future of the ulcerative colitis program, which also includes another candidate called SER-301. Previously, Takeda had licensed the two Finch treatments FIN-524 and FIN-525 for their development in IBD.
Lack of proper training of medical professionals restricts and hinders a safe and well-organized clinical trial. All these together can impose safety issues on the patient populations and risk the clinicalresearch company’s brand value. Open communication to ensure patient retention during clinical testing.
Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinicalresearch due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.
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 If you took a pill today, that was backed by research.”
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.
Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license. Many guidelines focus narrowly on clinical trials (including non-randomized studies) that are intended to generate data for regulatory submission to support a new drug license.
Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In June 2023, the U.S. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.
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.
In response to this authorization, FDA implemented binding guidance requiring submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Agency in eCTD format.
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. Psychedelic products are having a renaissance moment. billion in 2027.
While these NPDT products do not require FDA clearance, they must substantiate their claims with rigorous, clinicalresearch. These products require clinical trials to demonstrate their safety and efficacy before they can be prescribed by a licensed healthcare professional.
Executes Exclusive License Agreement with G1 Therapeutics for Global Development and Commercialization of Preclinical Cyclin-Dependent Kinase 2 (CDK2) Inhibitor Program Scientific Founders Comprised of Industry Experts with Proven Track Record of Successfully Delivering Innovative Oncology Therapeutics to the ClinicRESEARCH … Continue reading (..)
Completes License and Development Agreement with NONPI Medical LUND, Sweden–(BUSINESS WIRE)–Random Walk Imaging AB (RWI), a company developing novel software solutions for diffusion magnetic resonance imaging (MRI), today announced the launch of its first commercial software product for clinicalresearchers … Continue reading → (..)
“Traditional methods limit who can participate in a clinical trial and how quickly we can complete the clinical trial,” said Ahmad Namvargolian, Care Access’ chief executive. “We The two antibodies were discovered by Vanderbilt University Medical Center and licensed to AZ in June 2020.
Technological advances, changing patient preferences and evolving guidance from regulators and policy makers have all supported new research methods that break down barriers to participation.
Eventually it was bought by Amryt who, keen to get the drug licensed, resubmitted it to NICE in 2020. Sanders has been on metreleptin treatment herself for over 10 years, and from the start has been involved in fighting for access to the drug, engaging with the pharma companies, clinicalresearchers, and NICE.
Immunomedics had licensed the rights to the drug in Asian markets to Everest in 2019 for $65 million upfront and with up to $710 million in potential milestones, including $65 million due on US approval. The new deal means that the licensing deal has been terminated, and the Chinese pharma is no longer on the hook for any remaining payments.
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. They weren’t getting the relief they needed, and I wanted to help change that,” Amira adds. She decided to focus on patient recruitment to promote diversity in clinical trial populations.
PMRs/PMCs are studies or clinical trials that are conducted by the applicant after the Food and Drug Administration (FDA) has approved or licensed a product for marketing. These studies or clinical trials can be required either by regulation or statute (PMR), or by a written agreement, between FDA and the applicant (PMC). .
It is also dedicated to fostering innovations in care, clinicalresearch, health education and the support of community health. Kaiser Permanente has been providing not-for-profit healthcare plans for Americans across the US for 75 years now.
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 clinicalresearch trials include broad swaths of global participants.
Patient dosing has begun in a Phase III clinical programme investigating GlaxoSmithKline’s 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, Bexsero and Menveo. Invasive Meningococcal Disease (IMD) is uncommon, with country-specific reported cases ranging from 0.1
In addition, clinicalresearch may provide new information and breakthrough treatments. . The Benefits of ClinicalResearch for Pediatric Dermatology Conditions. Although there is currently no cure for either psoriasis or eczema, clinicalresearch is constantly working to develop new and improved treatments.
Speaking with a licensed therapist can help you manage these overwhelming feelings and help you improve your overall quality of life. Contact Olympian ClinicalResearch. At Olympian ClinicalResearch, we understand how difficult it can be to cope with a loved one’s Alzheimer’s diagnosis.
If you’ve been around the clinicalresearch industry, the concept of obtaining electronic consent is probably familiar to you. A secure solution also provides various methods of document authentication by requiring participants to upload multiple forms of identification such as a state ID, driver’s license, and/or a health card.
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