Development Approval Process Drugs - Food Safety


Did anyone know there is a new cure for cancer?

NOV 002 is now Waiting for FDA Approval.

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Novelos Therapeutics Obtains FDA Fast Track Designation for NOV-002 Lung Cancer Treatment
Monday August 7, 8:30 am ET

NEWTON, Mass.--(BUSINESS WIRE)--Aug. 7, 2006--Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the Food and Drug Administration (FDA) has granted Fast Track designation to NOV-002 for use in combination with first-line chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC). The FDA's Fast Track program is designed to facilitate the development and accelerate the review process for new drugs that have the potential to address a serious and unmet medical need for conditions such as advanced NSCLC.
Right now, Novelos Therapeutics is accepting patients for their adjunct chemo.
Limited to only 840 lung cancer.

Lung Cancer patients can contact:

http://www.clinicaltrials.gov/ct/show/NC T00347412?order=2


Ovarian Cancer patients can contact:

http://www.clinicaltrials.gov/ct/show/NC T00345540?order=1

Untreatable Hep C patients:

http://www.clinicaltrials.gov/ct/show/NC T00372983?order=3

If my links do not work please contact me.


There is a Phase III clinical trial to find out whether or not the combination of NOV-002 with chemotherapy (paclitaxel and carboplatin) is better at improving overall survival time when compared to chemotherapy alone in people with non-small cell lung cancer (NSCLC).

http://www.clinicaltrials.gov/ct/show/NC T00347412?order=1

It's not a cure for all cancer and the benefits for other cancers (Ovarian) remain to be investigated.

can someone help me re-phrase this?

A blind or blinded experiment is a scientific experiment where some of the persons involved are prevented from knowing certain information that might lead to conscious or unconscious bias on their part, invalidating the results.

For example, when asking consumers to compare the tastes of different brands of a product, the identities of the latter should be concealed — otherwise consumers will generally tend to prefer the brand they are familiar with. Similarly, when evaluating the effectiveness of a medical drug, both the patients and the doctors who administer the drug may be be kept in the dark about the dosage being applied in each case — to forestall any chance of a placebo effect, observer bias, or conscious deception.

Blinding can be imposed on researchers, technicians, subjects, funders, or any combination of them. The opposite of a blind trial is an open trial. Blind experiments are an important tool of the scientific method, in many fields of research — from medicine, forensics, psychology and the social sciences, to basic sciences such as physics and biology and to market research. In some disciplines, such as drug testing, blind experiments are considered essential.

The terms blind (adjective) or to blind (transitive verb) when used in this sense are figurative extensions of the literal idea of blindfolding someone. The terms masked or to mask may be used for the same concept. (This is commonly the case in ophthalmology, where the word 'blind' is often used in the literal sense.)



double blind

A testing procedure, designed to eliminate biased results, in which the identity of those receiving a test treatment is concealed from both administrators and subjects until after the study is completed.





Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, devices, therapy protocols). These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.

Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be a governmental organization, a pharmaceutical, or biotechnology company. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization.


Clinical trials were first introduced in Avicenna's The Canon of Medicine in 1025 AD, in which he laid down rules for the experimental use and testing of drugs and wrote a precise guide for practical experimentation in the process of discovering and proving the effectiveness of medical drugs and substances.[6] He laid out the following rules and principles for testing the effectiveness of new drugs and medications, which still form the basis of modern clinical trials:[7][8]

1."The drug must be free from any extraneous accidental quality."
2."It must be used on a simple, not a composite, disease."
3."The drug must be tested with two contrary types of diseases, because sometimes a drug cures one disease by its essential qualities and another by its accidental ones."
4."The quality of the drug must correspond to the strength of the disease. For example, there are some drugs whose heat is less than the coldness of certain diseases, so that they would have no effect on them."
5."The time of action must be observed, so that essence and accident are not confused."
6."The effect of the drug must be seen to occur constantly or in many cases, for if this did not happen, it was an accidental effect."
7."The experimentation must be done with the human body, for testing a drug on a lion or a horse might not prove anything about its effect on man."
One of the most famous clinical trials was James Lind's demonstration in 1747 that citrus fruits cure scurvy.[9] He compared the effects of various different acidic substances, ranging from vinegar to cider, on groups of afflicted sailors, and found that the group who were given oranges and lemons had largely recovered from scurvy after 6 days.
yes thats the whoel point og havign rich parents, you dont have to do any work, you have the fanacial security! just get a rich husband and i have even more money


Let's get this straight. You've ripped off a page from http://en.wikipedia.org/wiki/Clinical_tr ial because you can't be bothered doing any real work or you're too stupid to do so. Now you want someone else to rewrite it for you because you know that your teacher's going to check Wiki because he/she knows that you're too stupid or lazy to have done any real work. Good stuff! Nobody else will figure it out.



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In recent years the FDA has been heavily scrutinized for making the approval process more difficult for drug developers. A ground breaking study released this year by the BIO and BioMedTracker finds that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is a mere ten percent. The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides equity research on Dendreon Corporation (NASDAQ: DNDN) and Biodel, Inc. (NASDAQ: BIOD). Access to the full company reports can be found at:

www.bedfordreport.com/DNDN

www.bedfordreport.com/BIOD

Previously the rate of approval was one in five to one in six. Oncology drugs faced the toughest road to approval despite the fact that the disease area is the most closely studied in all of drug development.

Janet Woodcock, the head of the FDA's drug division, is quick to dismiss concerns regarding the FDA's approval process. This summer in testimony before the House Energy and Commerce's health subcommittee, Woodcock explained the agency meets more than 90% of deadlines that are part of the drug-review process. She also said so-called first cycle approvals are at a 20-year high with and said more than two-thirds of new drugs being approved within the six-to-10-month time frames given to new drug applications.

Fibrosis drug pirfenidone fast-tracked for approval in US, says ...

Pirfenidone is indicated for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

Pirfenidone granted Seniority Reviewing designation for the New Narcotize Bearing (NDA), InterMune, Inc said.

Immediacy Inspection designation may be granted by the FDA to an NDA for drugs that make available biggest advances in treatment, or anticipate a treatment where no all right psychoanalysis exists.

Immediacy Look at designation has the unrealized to speed the NDA approval process by reducing the aim comment on years for the relevancy from close to 10 months to six months. Based on the Formula Upper Buyer Fee Act (PDUFA), the FDA has set an encounter era for the NDA of May 4, 2010.

Preclinical and in-vitro prove had shown that pirfenidone has both anti-fibrotic and anti-rousing effects.

Results from three Form 3 studies have shown that pirfenidone treatment is striking in IPF patients.

Pirfenidone has been suitable and as a rule well tolerated, with the most banal side effects including photosensitivity precipitate and gastrointestinal symptoms.

“We are satisfied to have begun the inspect process of the first NDA submitted to FDA for a panacea for IPF patients and we look promote to working with the Pulmonary-Allergy Partitioning to executed the look at as expeditiously and thoughtfully as on,” Dan Welch, chairman, chief governmental tec and president of InterMune stated.

InterMune licensed pirfenidone from Marnac, Inc. and its co-licensor, KDL GmbH, in 2002 and in 2007 purchased from Marnac and KDL the rights to traffic in the multiply in the Shared States, Europe and other territories except in Japan, Taiwan and South Korea where rights to the molecule were licensed by Marnac and KDL to Shionogi & Co. Ltd. of Japan.

In October 2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa by Shionogi in that mother country.

What is idiopathic pulmonary fibrosis?

Idiopathic pulmonary fibrosis (IPF) is a disabling and fundamentally fateful disorder that affects generally 200,000 patients in the Of one mind States and Europe combined, with give 30,000 new cases reported per year in each of the Pooled States and Europe.

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