The FDA gets very concerned about drugs that could elevate this QT interval into a worrisome zone.
The FDA is very demanding and has a standard set of Good Manufacturing Practices to which all ingredient manufacturers as well vitamin or supplement manufacturers using these ingredients must comply to.
Steven Nissen at the Cleveland Clinic, an FDA panelist who voted to keep Bextra on the market, said that he thought the FDA had acted very reasonably.
But the FDA has been very cautious before finally issuing approval for these two drugs, citing concerns over potential side effects and consumers who may lobby physicians unnecessarily for prescriptions.
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Because the FDA's questions focused on whether there was a risk and whether the data available was powerful enough to reach a conclusion, the FDA actually got very little feedback on the topic where panelists might have helped the most: how to warn patients of a risk that may well be there.
On Monday, the FDA turned a halted clinical trial into a very scary warning about Aleve (see: " FDA Statement On Naproxen").
Under the current law, approved in 1992, the very manufacturers the FDA is supposed to scrutinize pay the salaries of drug reviewers.
There are many cases where all clinical trial results are not submitted to the FDA, and this is very well illustrated in, for example, the ongoing 2012 scandal over Tamiflu (discussed at length in my book, which LaMattina has not read).
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And it is very likely that the FDA is still a long way away from loosening up.
Some would-be reformers argue the FDA is being poisoned by the very money that keeps it going.
He is very concerned that the FDA is not paying close enough attention to the important health issues relating to mercury poisoning.
These drugs to treat rare cancers and other uncommon diseases were approved very quickly by the FDA, then went on to reap big sales.
He still sells the very same products that the FDA warned him about: he merely changed the way he advertises them.
The suit was probably more a way to send a very public message to the FDA that it should make a decision about Ranbaxy and consider the cost implications for the public at large.
As Pfizer and Merck defend themselves against lawsuits related to those drugs, having that kind of the argument--from the FDA, no less--could be very useful.
Now, I think the odds that the FDA will go against its advisory panel and approve lorcaserin are very low, but if that happens, the stock will soar.
But today it has announced FDA approval for Tygacil, a new antibiotic that may be very useful at treating infections where there are multiple types of resistant bacteria, or where the pathogen can't be identified.
But there were strings: The FDA demanded a fourth big study to confirm the drug's very modest efficacy before it would give final approval.
The FDA has approved a new prescription formulation of fish oils for the treatment of very high levels of triglycerides.
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Called the Enterra, it was approved in 2000 under the FDA's humanitarian device exemption, which is for devices that target a very narrow group of patients.
It has no FDA approved instrument or can really control 100% of its chemistry production, we are indeed very far from a full clinical systems hospitals are known for.
The FDA approved the drug and kept it on the market for a long time, despite a very modest weight loss benefit and obvious problems with the safety of the drug.
The FDA says no link has been proven between Monster and any deaths, but that it takes all reports "very seriously'' and "diligently'' investigates them.
But surprisingly, very few were about whether the pricing policy was fair to patients, represented good policy by the FDA, or about what moral obligations a company might have to do the right thing.
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"There are very, very strong opinions and powerful voices both on the consumer and public health side and on the industry side, and we have worked very hard to sort of figure out what really makes sense and also what is implementable, " FDA Commissioner Margaret Hamburg said in a recent interview with The Associated Press.
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