Word: fda
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...disheartening case of politics trumping science, the Food and Drug Administration (FDA) recently repudiated its own expert advisory panel and rejected over-the-counter sale of the emergency contraceptive Plan B, more commonly known as the “morning after pill.” We have long supported the over-the-counter sale of Plan B, and we hope that the FDA will reconsider its unfortunate ruling...
Under U.S. law, the FDA is required to approve drugs for sale so long as their safety and efficacy are confirmed. However, in the case of Plan B, it seems that the FDA disregarded protocol in hopes of gratifying conservative interests. In fact, two FDA officials, acting director of the FDA’s Center for Drug Evaluation and Research Steven Galson and acting FDA commissioner Lester M. Crawford are being urged to resign for playing politics at the FDA. Some congressmen are also calling for an investigation of the FDA in order to determine whether their dealings were...
...Fund to Fight AIDS, Tuberculosis and Malaria and even the U.S. government itself have used WHO certification as a basis for their drug procurement policies. That’s because the WHO approval process is extremely rigorous. In fact, the additional regulatory conditions proposed by the administration exceed current FDA protocols...
...that it’s beginning to feel some heat, the administration is reassessing its alternatives. The latest news is that they’re working to construct an expedited FDA approval process that could sanction FDC procurement in a matter of months. We’ll see. It is unlikely that any such process will be set up before September, at the earliest. In any case, establishing a parallel approval process to the WHO’s is not the solution. This would just pave the way for political interference in future scientific decisions and, as Waxman notes, lead...
Second, there is the confusing notion of net carbs. Some manufacturers subtract the good carbs from the bad ones and advertise the difference. This is a slippery slope because the FDA insists that a carb is a carb is a carb. So net carbs are not the same as fewer carbs...