A company named Replidyne wanted to get fast track approval for its faropenem medoxomil drug but suffered a shock when FDA said that the company should further conduct tests for the drug rather than getting it approved in a fast track manner. This drug can be used in treating pneumonia, sinusitis, chronic bronchitis and other types of skin infections. FDA wants an exhaustive study to be conducted and termed the study conducted by the company to be insufficient for getting approval. The company was hopeful that it would easily get the approval of FDA. The probable reason was that FDA has changed its requirements since it started the approval process and now wants companies to prove that their drug is not only effective but superior to the alternatives available in the market. I believe that it a correct move by FDA because a number of drugs are being developed under the umbrella of biotechnology and most of them have not been able to meet the expectations. It seems FDA wants to play safe.
Tag Archive for FDA
This comes as shocking news for VaxGen. FDA has postponed the advanced testing of anthrax vaccine being developed by the company. The second mid stage clinical trials of the vaccine were about to begin. The reason for this is that FDA found out the data submitted by the company was insufficient to prove that the stability of the product was enough for starting the clinical trials. This vaccine was meant to prevent diseases, which might be caused due to inhalation of anthrax spores, and as per the BioShield project, millions of doses of the vaccine had to be stocked. The company has still not stated how much time would be required for addressing the concerns of the FDA. This delay might lead to losses for the company as the order for stocks worth $1 billion by the Department of Health and Human Services might be terminated.
Good news for breast cancer patients!! FDA has given expanded approval to Herceptin which is a breast cancer drug in order to treat women who underwent surgery. In the clinical trials which were conducted it was found out that those patients who were administered drug along with chemotherapy suffered fewer relapses as compared to those who were only subjected to standard chemotherapy. This medicine is aimed at those patients in whose case the breast tumors produce significant amount of protein called HER-2 and world over every year 250,000 are detected with HER-2 positive. Herceptin got the approval in 1998 for treating breast cancer after it reached out to other parts of the body and this expanded approval is aimed at patients whose breast or lymph node has been removed surgically.
FDA has given the approval for cloned milk and meat but this has raised a number of questions among the people. Some experts believe that cloned food should be labeled as organic food only if it has been raised in an organic way. On the other hand some people are not quite happy with the fact that cloned food should be awarded an organic label. This debate will continue until an advisory panel comes up with a solution on this issue but most of the people believe that opponents would emerge victorious in this debate and the word organic clone would be included soon. This would not be an easy job and it would be quite difficult to regulate this science since it keeps on changing. Jerry Redding, USDA spokesman said: The Agriculture Department spent years crafting a definition of ”organic,” integrating the advice of record-breaking 50,000-plus public comments. But even after all that the issue of clones ”really never came up internally or externally until the FDA made its announcement about cloned animals being safe Let’s see how far the debate goes, till then wait and watch!!
You are skeptical about consuming cloned food but it might be difficult to distinguish whether the product placed on shelf is cloned or not as FDA has decided that there would be no special labels put on these products as the government states that it has not found any major difference between cloned and conventional livestock. Shocked but don’t worry as in order to sort your confusion the round green USDA organic seal would be used. This label would also imply clone free product. Up till now people have given a mixed reaction whether they would be comfortable with consumption of cloned food or not. We will have to wait for the reaction of people when cloned food reaches the retail shelf and then only the picture would become clear. Also if the government has found no problem in case of cloned food then it should make an effort to popularize it and remove all the misconceptions in the mind of the public.
FDA has given the green signal to a new type of absorbable suture created from material which has been isolated from bacteria modified by recombinant DNA technology. Called as TephaFLEX Absorbable Suture, it has been developed by Tepha and has been made from designer biomaterials. These sutures are based on a technology which is based on natural materials called polyhydroxyalkanoates or PHA polymers and have been synthesized by various microorganisms. When compared with other polymers these polymers are thermoplastic and hence can be processed like the plastic used as of now. The biomaterials have been developed through proprietary transgenic fermentation process which is similar to one used for producing biopharmaceuticals but results in a very high yield. The company is also looking to incorporate polyhydroxyalkanoates in various implantable medical devices such as vascular grafts and artificial cardiac valves.
The Food and Drug Administration is facing criticism over its recent preliminary approval to food from cloned animals as a consumer group has charged the agency for using flawed analysis. According to the Center for Food Safety, the FDA could not find studies on milk or meat from clones and whether they’re safe and the agency relied on studies done on cloned animals and whether they appeared healthy. Claiming that the conclusions drawn by the FDA was based on ‘scant data from few peer-reviewed studies’, Charles Margulis, a spokesman for Center for Food Safety, said: There isn’t the science to show that these foods are safe. I think the agency was heavily influenced by the biotechnology industry. Though FDA was tight lipped, Val Giddings, a scientist who consults with biotechnology companies, has come forward in FDA’s defence. According to Giddings an exhaustive amount of peer-reviewed data was the base of the conclusion. Giddings said: There’s not a single shred of data to suggest that food derived from clones or their offspring is in any way unsafe. All of what FDA has done here has been completely transparent. The FDA found that food from clones and food from conventional livestock has no virtual difference between and therefore special labels for cloned food would be necessary. Center for Food Safety might be in the process of waging a war against the FDA but Dean Foods Co. of Dallas has already decided to go against the idea of cloned food. Nations biggest milk company has decided it would not sell milk from cloned cows. The company’s decision was influenced by various surveys suggesting the dislike for dairy products from clones by Americans. Source.