REMS Preemption
fejotodd
We're so sad: Now that Riegel v. Medtronic and Wyeth v. Levine have been decided, we can no longer bill ourselves as "all preemption, all the time!"

We're forced to write about other stuff.

Not so fast!

One of us was giving a talk a few weeks ago, and an audience member posed a good question: How does the new Risk Evaluation and Mitigation Strategy (or "REMS") provision, added by the Food and Drug Administration Amendments Act of 2007, affect preemption?

The answer, of course, is that only time will tell, because there aren't yet any cases involving drugs that went through the REMS process. But REMS does give defendants a chance to assert a preemption defense.

The FDAAA of 2007 adds a new section, 21 U.S.C. Sec. 355-1, captioned "Risk Evaluation and Mitigation Strategies." For previously approved drugs, the FDA may require a REMS if the FDA becomes aware of new safety information and decides that a REMS "is needed to ensure that the benefit of the drug outweigh the risks." Sec. 355-1(a)(2)(A). Other drugs will be "grandfathered" into having a REMS. (The FDA published a list of 15 such grandfathered drugs in March 2008.)

Once the FDA notifies a manufacturer of the need for a REMS, the manufacturer must submit one. The REMS may include viagra cialis online pharmacy pharmacy guides, patient package inserts, and communications plans (such as letters to health care providers) to mitigate the risk associated with the drug. Sec. 355-1(e)(2)-(3). The FDA will review and approve the REMS, and the manufacturer will effect it. The FDA will then assess the REMS periodically.

What does that have to do with preemption?

Potentially everything.

If the FDA identifies a drug risk, evaluates the drug to be sure that the benefits of the drug outweigh its risks, and works with the manufacturer to provide FDA-approved warnings that give proper notice of the risk, then the FDA has focused squarely on the risk in question.

That administrative record, showing that the FDA considered and acted on a specific risk, may establish preemption under the new framework established by Wyeth v. Levine.

As more drugs go through the REMS process, we'll surely see the preemption defense raised in this context.

We can hardly wait.

medical supply store
fejotodd
Viagra's customers can be divided into three groups: the royal group who are satisfied with Viagra and do not want to try another product, a group which can switch to another product, and a group who discontinued using Viagra. The last group may be the easiest one for online pharmacy viagra to gain. 50% of the patient who had tried Viagra stopped using it. There are three main reasons for discontinuing with Viagra: First, some patients think the price is too high. Second, the side effect for some patients is severe. And third, some patients turn to not concern their sex life anymore. The patients who stopped Viagra because of its side effects may easily be willing to try Cialis because Cialis is proved to be safer. Since Up to 80% of the ED problem was caused by physiological conditions such as high blood pressure, cardiovascular disease and diabetes, and these patients are more likely to be subject to the side effective and tend to have more concerns about the health risk proposed by ED drugs, safer can be a very important selling point for Cialis. Those patients who think Viagra's price is too high, can be divided into two subgroups: the one think Viagra does not provide good value for $12.5 for a single sex experience in rush (they have to finish everything within 4 hours), and the one who cannot add additional several 12.5 dollars in their living expenses. The first subgroup may become Cialis's customer if they think Cialis provides good value for its price. For the switching customers and the growing new customer, Cialis will have to compete with Viagra. beta1,3 glucan with aricept and namenda 3) Summary of Value Pricing for customers what is aricept for Other expense ($ million) 500 500 500 500 500 500 500 500 500 what is aricept for Flexibility: As Dr. Andrew Yip, president of Hong Kong Society for the Study of Aging Male once said " It (Cialis) help patients to get back to a normal sex life without having to count the hours before having sex" . The instant and longer effective hours of Levitra will certainly allow couples to have a more spontaneous, romantic and casual sex life. possible side effects of aricept 0.94MM in US, spent $1067 per year on average in 2002, 1.64pills per week (Table 3). In addition, Table 2 shows that 30% of me between 40-70 people have sex twice a week. We have a ballpark estimation that people on average seek sex twice a week. beta1,3 glucan with aricept and namenda beta1,3 glucan with aricept and namendaThere are possible future competitors for Cialis, e.g. Vivus Inc.'s TA-1790, which is now in phase and NexMed's Alprox-TD proprietary cream, which is in phase 3. We believe these possible future competitors still need a relative long time to be able to enter the market and there are many uncertainties tied to them. Therefore we did not include these future drugs in our later analysis. aricept down syndrome In our sensitivity analysis, we found that the percentage of R&D expense and the percentage of Royalty rate are the most two important factors to our result. Once again, if the percentage of R&D expense and the percentage of Royalty rate change from 10% to 90% of their possible value, the corresponding output change of the NPV (output variable) will be the largest. From this perspective, we can conclude that these two input variables (the percentage of R&D expense and the percentage of Royalty rate) have the highest influence on the NPV.fari nicolas m d and aricept aricept and uk study Because we don't have the market data for Cialis, we assume that Cialis will follow the same demand curve as in Viagra. So we used two data point for Viagra to estimate the Demand Curve as: . Then we can easily find the optimal price to maximize the revenue. The optimal price is: $17.5, with the demand = 78.4 million and revenue = 1.37 billion. (Table 8) 10mg aricept • Be safer. Since up to 80% of the ED problem was caused by recent studies on aricept aricept and uk study aricept and uk study beta1,3 glucan with aricept and namenda

Penis size
fejotodd
Most men do not think rationally about cheap viagra size.
  • Research has shown that men do not have a clear idea of the size of their own cialis. Looked at from above, it appears shorter than it really is.

  • Men do not have a clear idea of what average is.

     

What's normal?

According to the Kinsey Institute, many American men mistakenly think the average erect penis is 25 cm (almost 10 inches) long, and worry that they do not measure up. Here are the results of three surveys.
 
Firstly, the University of California researchers measured the penises of 80 normal men and published their results in the Journal of Urology in 1996. They found that:
  • without an erection (limp), the average length was 8.8 cm (just under 3.5 inches)

  • the average flaccid (limp) penis could be stretched to 12.4 cm (about 4.75 inches)

  • the average length when erect was 12.9 cm (just over 5 inches).

Of the men studied, many had penises that were larger or smaller than the average. They also found that the length of the penis when limp does not predict the size when erect – smaller penises expand more when erect. So, the researchers found the average erect penis to be about 13 cm long, regardless of whether it is 5 cm or 10 cm long when it is limp.
 
Secondly, in 2001, the condom manufacturer Durex asked men visiting its website to take part in a penis size survey, and just under 3000 men responded. They measured themselves and reported the results to the website. The average erect length was 16.3 cm (6.4 inches), and the average circumference (measured round the penis at its widest point) was 13.3 cm (5.2 inches). It is difficult to know how reliable these measurements are – there might have been some wishful thinking involved. The survey also showed that a long penis is not usually thick. Durex says, “While the ‘mythical’ well-endowed man with a very long and very wide penis does exist, there are not that many of them about.”
 
Thirdly, a survey of research has produced the following information (European Urology 2008;54:1042-50):
  • when limp, an adult penis is between 7.6 cm and 13.0 cm long (3–5 inches approx)

  • when limp, the normal girth (i.e. measured round) of an adult penis is between 8.5 cm and 10.5 cm (3¼-4 inches approx)

  • when erect, the normal penis length is between 12.7 cm and 17.7 cm (5-7 inches approx) 

  • when erect, the normal girth of an adult penis is between 11.3 cm and 13.0 cm (4½-5 inches approx).

     

Shoe size and penis size

It is a myth that men with large feet have larger penises; researchers have found no correlation (British Journal of Urology International 2002;90:586–7).
 

Lose a paunch

If you are carrying a few excess pounds on your abdomen, the first part (called the root) of your penis will be buried in the fat. This makes it look shorter than it really is. Losing weight will make the penis grow!

Penis enlargement

The shaft of the penis can be made thicker by injecting fat under the skin of the penis. The fat will have been removed by liposuction from another part of the body, usually the thigh or abdomen. The glans (the tip of the penis) stays the same size, and so it may look a bit out of proportion. The fat tends to be absorbed by the body, so the injections have to be repeated two or three times a year. The fat can sometimes form unsightly nodules, and there can be puckering of the skin and scarring.
 
Another method is dermal grafting. Strips of skin and underlying fat are removed from beneath the buttocks; the upper layer of skin is taken off and the rest of the tissue is implanted along the shaft of the penis under the skin. As a result, there may be some scar tissue along the shaft of the penis.
 
The penis can be made longer by a surgical operation in which the ligaments that attach the penis to the pubic bone are cut. This makes the penis hang down about 2.5–5cm (1–2 inches) further when it is limp, but the size of your erection will not be increased. Also because it no longer has the support of the ligaments, the erect penis will not point as high as before. The operation can be risky, because important nerves that carry sensation can be damaged and infection or bleeding can also occur, and unsightly scarring is common. If you are considering this operation, make sure that you find a reputable surgeon (look at the section on cosmetic surgery). This may be difficult, because not many surgeons are willing to do this operation, because of the problems associated with it.
 
A safer approach is to have a ‘suprapubic lipectomy’ to remove fat from the lower abdomen above the root of the penis. This makes the whole length of the penis more visible.
 
For more information, Dr Phil Hammond discusses Helix marks and penile enlargement in his Expert guide.

Beware of Pain Medication Addiction
fejotodd
Medications have become an unavoidable part of our lives. These medications are supposed to improve quality of life for an individual suffering from depression, anxiety, schizophrenia and bi-polar disorder. Pain medications make life bearable to those suffering from accidents, injuries, and surgeries. Unfortunately there are many addictive medications that can have very disastrous results if given over to them.

Pain Management Clinics observed that pain medications are one of the most common types of medications that can develop into an addiction if not carefully monitored by your health care professional. In this regard they have offered some Pain Medications which are very useful in combating pain. If you go for ordinary medications you will get addicted to them ultimately making your life more difficult.

Chronic Pain Treatments are one of the amazing advancements of modern medicine and are extremely useful and helpful if given and monitored in a correct manner and abuse does not develop. Loved ones of those taking pain medications should educate themselves to be able to see any warning signs that the patient is becoming addicted to the medications designed to help them heal. Being educated on the many different warning signs of pain relief cheap cialis addiction could save the life of your loved one taking the medication.

After you have educated yourself on the signs of addiction, discovering that your loved one is addicted to Pain Relief medication is very a difficult, but necessary realization that must occur for your loved one to receive help. Obviously the faster the addiction is treated the better as a pain pill addiction can easily turn into a more dangerous addiction to heaver narcotics.


California DMV Hearing Officer Lies
fejotodd
A recent DMV Hearing was held where the Hearing Officer, Ms. Kaur, LIED; GRANTED A SET ASIDE, then did an Ex Parte Communication with another Hearing Officer, and changed her mind, and did not grant the Set Aside. She refused to go on the record for part of the argument as to the Ex Parte Communication and had to be threatened with criminal action before she would divulge the other person's name. Next, she lied about having notice of the Respondent having GERD a defense to breath testing, then stated he could have his purchase cialis fill out a Medical Form, then had another Ex Parte Hearing with a supervisor, who told her that the cialis did not state under penalty of perjury on the page he wrote, although it is on the form, so she could only accept it if he signed the page under penalty of perjury, then changed her statement that the doctor had to testify. Next, the doctor did testify, and said the he reviewed the patients endoscopy showing GERD and that it had been present for at least 2 years and that he was in a constant state of regurgitation 24/7 365 days a year whether he knew it or not. She stated in her report the doctor said he couldn't tell if the person was in this state at the time of testing; A LIE. Additionally, she is trained to put into the report and ignore the Toxicologist who testified that the regurgitation invalidates the test per State law Title 17, Section 1219.3, and he was not credible. She was told to bring in a medical doctor for rebuttal, refused, and suspended a license with deliberate ignorance of human anatomy and physiology, ignoring the Medical Doctor, and State law. This is the reason these unqualified people should not be handling hearings as if they were legally trained and acting as Judges. I doubt this person even has a any college training, let alone legal education. And just like all other people in the government, we do nothing, and no penalties, including costs, are awarded against this despicable disregard for the law. Ms. Kaur has had other case reversed against her incompetence of legal issues. So, if you have her as Hearing Officer in your case, have your lawyer challenge her as biased and untrustworthy.

California DMV Hearing Officer Lies
fejotodd
A recent DMV Hearing was held where the Hearing Officer, Ms. Kaur, LIED; GRANTED A SET ASIDE, then did an Ex Parte Communication with another Hearing Officer, and changed her mind, and did not grant the Set Aside. She refused to go on the record for part of the argument as to the Ex Parte Communication and had to be threatened with criminal action before she would divulge the other person's name. Next, she lied about having notice of the Respondent having GERD a defense to breath testing, then stated he could have his cheap cialis fill out a Medical Form, then had another Ex Parte Hearing with a supervisor, who told her that the cialis did not state under penalty of perjury on the page he wrote, although it is on the form, so she could only accept it if he signed the page under penalty of perjury, then changed her statement that the doctor had to testify. Next, the doctor did testify, and said the he reviewed the patients endoscopy showing GERD and that it had been present for at least 2 years and that he was in a constant state of regurgitation 24/7 365 days a year whether he knew it or not. She stated in her report the doctor said he couldn't tell if the person was in this state at the time of testing; A LIE. Additionally, she is trained to put into the report and ignore the Toxicologist who testified that the regurgitation invalidates the test per State law Title 17, Section 1219.3, and he was not credible. She was told to bring in a medical doctor for rebuttal, refused, and suspended a license with deliberate ignorance of human anatomy and physiology, ignoring the Medical Doctor, and State law. This is the reason these unqualified people should not be handling hearings as if they were legally trained and acting as Judges. I doubt this person even has a any college training, let alone legal education. And just like all other people in the government, we do nothing, and no penalties, including costs, are awarded against this despicable disregard for the law. Ms. Kaur has had other case reversed against her incompetence of legal issues. So, if you have her as Hearing Officer in your case, have your lawyer challenge her as biased and untrustworthy.

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