Safety cases effectiveness

Class III devices, unless they are substantially equivalent to a device already marketed without a PMA appHcation, require formal PDA approval through the PMA process before initial sale. The PMA process is comparable to the new dmg approval process (18). In both cases, safety and effectiveness data must be reviewed by PDA prior to marketing. An approved PMA appHcation acts like a private Hcense granted to the appHcant to market a particular device. Other firms seeking to market the same type of device for the same use must also have an approved PMA. 

Advisory committees. There is no statutory requirement that FDA review the approval of an NDA with an advisory committee before final action is taken. Since the 1970s, however, this has been the customary practice, particularly with important new drugs. This prompted Congress to enact a specific provision dealing with the establishment of drug advisory committees under the FDA Modernization Act of 1997. The review of an NDA by an advisory committee is an extremely important step in the approval process. It represents the best opportunity that the applicant has to address the agency and the public about the evidence of safety and effectiveness and the importance of the drug to public health. In the vast majority of cases, FDA accepts the recommendation of the advisory... 

Clinicians should be aware that many of their patients may be taking alternative treatments either via self-care or prescribed by CAM practitioners. Inquiring about this should be routine because of potential side effects and drug interactions. A working knowledge of CAM treatments will allow child psychiatrists to give parents and patients advice about safety and effectiveness. Use of St. John s wort in children with unipolar depression may at times be appropriate, particularly in cases where more standard treatments are contraindicated or have failed. However, it should be used cautiously and with an appropriate explanation of its risks and benefits, as a competent clinician would do for any treatment. Use of St. John s wort for other conditions is not currently recommended given the lack of evidence for efficacy. Kava extracts may be used for anxiety, with similar provisos. There are much fewer data about the efficacy and safety of other dietary supplements and their use cannot be supported at this point. 

DoD is not just another purchaser in a commercial market, however. It becomes a developer of drugs when demand is mainly or exclusively for military use. Under these circumstances, DoD requirements for CBW defense drugs involve the department in the full spectrum of research, development, testing for safety and effectiveness through clinical trials or alternate means, production, acquisition, and issues of medical use. (This may also be the case for naturally occurring diseases that rarely appear in the United States and for which the domestic civilian market is limited.)... 

The law of 1906 was only a beginning. It did not regulate the safety and effectiveness of drug formulations. This was no more evident than in the case of mass poisoning which resulted from the consumption of "elixir of sulfanilamide" produced by the S.E. Massengill Company of Bristol, Tennessee. Between September and October 1937 doctors had prescribed almost 12 gallons of a 10% solution of sulfanilamide in an ethylene glycol(antifreeze) solvent flavored with saccharin, caramel, amaranth, and raspberry extract. The company s chief chemist, Harold Watkins, was not aware of the toxicity of that concentration of the solvent. 

As far back in history as the Greek physicians Hippocrates, Pliny, and Galen, through to present time, the herb St. John s wort has been used for its antidepressant effect. It is believed to influence the neurotransmitters in the brain. Although some research has shown it to be effective in cases of mild to moderate depression, many questions remain as to its safety and effectiveness. 

Comparability Program As with the Fortical case study, Omnitrope and Genotropin differed in certain aspects. As such, Sandoz was required to submit substantial data to establish that Omnitrope was sufficiently similar to Genotropin to warrant reliance on FDA s finding of safety and effectiveness for Genotropin to support the approval of Omnitrope [18]. 

The statute requires that a new drug be shown to be both safe and effective. Because no drug has ever been shown to be completely safe or effective, in all cases this has been interpreted to mean that the benefits of the drug outweigh its risks under the labelled conditions of use for a significant identified patient population. The statute is very broadly worded with respect to the required proof for safety and effectiveness, and... 

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