Daily visits to selected websites, subscriptions to selected scientific and medical podcast as well as my monthly magazines such as Nature, Scientific American, Physics Today, Science Magazine and Science Readers. respirate just convinced me to add the FDA website into my dailies.
What is good with technology these days is that you can be very selective regarding the kind of information you want to get and newspapers make me angry for some reasons that are totally personal.
Also, Avandia is the other drug that falls into this classification. The FDA warns not to use Avandia for first time users, in fact, the FDA severely restricts its use.
You can read about the different oral diabetes medication classifications and drugs that fall into each class here.
http://tinyurl.com/type2-diabetes-drug-classes
Always ask your doctor why he/she is Rx a drug vs others on the market.
I use Actos, but for some reason my fingers typed Avandia. Our FDA went through the same review on Avandia recently, and reluctantly left it on the shelf; however, it is used only when patients are found refractory to other, similar drugs, I believe.
FlGuy, although I was down to 185 pounds at one point during treatment, I’m currently the lankiest 6’ 0” 250 pounder you’ve ever seen :o). I’ve always led an active lifestyle, so I don’t fit the sedentary profile of typical DM II patients.
" This permits the FDA to review the filing as it is received, rather than waiting for the entire submission prior to commencing the review process. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which would reduce the length of the standard FDA review period."
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This is fantastic news! Fast Track?
, approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit
Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
org/wiki/Thiazolidinedione
this drug is same family as Rosiglitazone (Avandia) which has been foud active on hbsag and hbvdna, question is does TZD lower hbsag since decrease of hbsag inibits cancer growth too and if lowered to und eradicate hbv?
GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options.
She is gaining weight, has trouble breathing, and has been experiencing some chest pains lately (Dr. gave nitro). She is on avandia and I would like to know if this could be the cause of her recent decline in health?
The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naive patients with genotype 1, 4, 5 and 6 HCV infection.
Should the government shut down for any length of time, the FDA review could be delayed.
The FDA grants priority review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. FDA review will begin approximately 60 days after receipt of the application and will aim to be complete within six months from when the review period begins.
, approval on an effect on a surrogate or substitute endpoint reasonably likely to predict clinical benefit
-- Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
I have heard various reports about how the shutdown will affect the FDA PDUFA review/approval process. I read this morning that the Sofosbuvir FDA Panel Review Date Set for October 25th has NOT been cancelled and that since the review/approval process is fee based that it will continue, at least until funds from fees collected to date have been exhausted. Anybody else heard anything? Sofosbuvir and Simeprevir are both set for their approval decisions in the next couple of months.
Figure 17 tells us the overall ILLUMINATE SVR rate was 74%, confirmed in the FDA review, and then goes on to justify why 24 is not inferior to 48 among the eRVRs.
However, it seems that at no point is the SVR statistic for the eRVR- subgroup ever given. Tables 18 and 19 tell us many details about them (genotype, fibrosis, race, etc.) but never answer the main question.
Should be getting some news on the Telaprevir approval process in the next couple of weeks.
From the 11/23/10 vertex press release on filing the application
"The submission includes a request for Priority Review, which would reduce the FDA’s review time from 10 months to six months. The FDA grants Priority Review status for several reasons, including if the medicine is considered a major advance in treatment.
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