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Tag: "regulatory" at medical news

Detecting DNA Damage With In-Vivo Alkaline Comet Assay

...sion. There is a positive movement towards formal regulatory acceptance of the assay, which has resulted in increasing demand for the in vivo Comet assay. In response to this demand, RCC Cytotest Cell Research has established and validated protocols for different cell types. In order to make a comparison wit...

Monitoring Drug Safety

...d with disseminating emerging information prior to regulatory action. In addition, FDA will actively seek feedback from healthcare professionals and patients on how best to make this information available to them. A cornerstone of all information collection, evaluation, and communication proposals in an age of...

Advent of New, More Effective and Personalized Medicines

...submissions, and the data that will be used during regulatory decision-making. The guidance also explains a new ...ternal, agency-wide group and will not be used for regulatory decision making, but will help FDA and industry gain valuable experience. FDA believes this approach...

Drugs Banned worldwide still available in India

...harmaceutical companies thereby affecting the drug regulatory mechanism in India and until such issues are not sorted out the existing situation would prevail. ...

The Use of Radio Frequency Identification ( RFID) to tackle the growing menace of counterfeit drugs

...ies, packaging companies, machinery manufacturers, regulatory authorities and retailers are necessary to curtail this menace....

Athletes Warned Of Exercise-Associated Hyponatremia

...s sodium level, interfering with the body’s normal regulatory processes. The key to preventing EAH is to avoid drinking a larger volume of fluid than the body loses in the form of sweat and urine. Formulas are available for estimating hourly sweat loss during exercise—however; a good rule of thumb is to drink ...

Ban On Indian Ayurvedic Drugs In Canada

The drug regulatory agency in Canada , Health Canada has warned //the...da. Canadians have also been advised by the drug regulatory agency not to use any Kerela, Safi, Maha Sudarshan Churna, Yograj Guggul, Sudarshan or Shilajit pro...

Gene in Melanomas

...enders the Cdk4 protein insensitive to a family of regulatory molecules that normally play a role in switching it off, known as INK4 proteins.The INK4 proteins usually have a 'double-negative' effect, blocking Cdk4's neutralising effect on another growth-suppressing protein. When INK4 proteins are disabled, cel...

Ranbaxy opens Drug discovery centre in Gurgaon

...Ranbaxy has another R&D building, which houses its regulatory and administrative departments. The focus areas for research for Ranbaxy are infectious diseases, urology, respiratory/inflammatory and metabolic diseases. ...

Role Of Estrogen In Breast-Cancer

...depletion of estrogen is associated //with loss of regulatory protein. The scientists report that human breast-cancer cells exposed to estrogen in their laboratory showed a dramatic reduction in numbers of a crucial nuclear receptor corepressor, a protein known as N-CoR . They also found that the anti-estroge...

Health Minister fires another salvo at MCI

...country. He said: "influence of mafias over such a regulatory body was // a matter of grave concern." The MCI is an autonomous body and the government has no say in its functioning. What irks the minister is lack of transparency in its functioning. He said a cleansing process of the councils was a major c...

Novartis MS Drug Shows Promising Results

... II study results, Novartis is in discussions with regulatory authorities about the FTY720 Phase III program, which is expected to be launched by the end of 2005. Over two million people worldwide are estimated to suffer from multiple sclerosis, which is the leading cause of neurological disability in young a...

New Hope For Patients With Relapsing Multiple Sclerosis

...urope and Canada), Novartis is in discussions with regulatory authorities about the FTY720 Phase III program, which is expected to be launched by the end of 2005....

Therapeutic Monoclonal Antibody Production Is More Profitable Than Small Molecule Drugs

...h there is respectable data showing that obtaining regulatory approval tends to be easier for antibodies than for other drug classes, he warns it is too early to make firm predictions. “The mid and longer term future may look quite different in terms of competitive threats, so past performance is not necessaril...

Evoprinter, a multigenomic comparative tool for rapid identification of functionally important DNA

Deciphering the regulatory mechanisms that control coordinate gene expression is a long-standing goal of biology. The comparison of orthologous DNA sequences from multiple vertebrate or invertebrate // species holds promise in identifying the cis-regulatory elements central to...

Bifidogenic Growth Stimulator: A Non-Toxic Way To Treat Ulcerative Colitis

...s, tissue damage can result from failure of normal regulatory constraints on the mucosal immune responsiveness to intestinal bacteria. Therefore, restoring the microbial balance may represent a plausible therapeutic approach in the treatment of UC. Experimental studies have shown that luminal antigens are inv...

Historic trial for tuberculosis launched together by leading drug companies

...in for each trial site and will cover the costs of regulatory filings. The TB Alliance will coordinate and help cover the costs of the trials."We are witnessing an historic moment in global health," said Dr. Maria C. Freire, President and CEO of the TB Alliance. "Today, we stand with Bayer, embarking on a major...

India to maintain Public domain Registry database of clinical trials conducted in India.

...n underlined the need for a strong legislative and regulatory framework for clinical trials and addressing ethical issues. Experts View: Ashwani Kumar, Drug Controller General of India said, “Multi-centric clinical trials would be allowed on the same protocol as followed in the US and Britain, presently multi...

Drug companies in India keen on developing bird flu drug

...re the drug can actually be manufactured following regulatory approvals. In response to the above situation, Roche has announced it would not welcome interventions by generic drug makers in Tamiflu market, the demand for which has increased manifold following reports that the pandemic has reached Europe and SE...

High concentration of heavy metals in Herbal medicines

... intakes of 1,000 to 10,000 times greater than the regulatory standards. It has now been made mandatory that all herbal products should be tested for their heavy metal content prior to export. The notification has been issued by the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AY...

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