Approval of drugs

FDA is able to rely on less well-established surrogates for accelerated approval of drugs that provide meaningful benefits over existing therapies for serious or life-threatening illnesses, such as AIDS, rare carcinomas, or breaking infectious diseases. In these cases, the... 

Research participants are the true pioneers of medicine. Through their participation, novel therapeutic cures and treatments have been made possible. Furthermore, their participation also protects the public from approval of drugs that have a poor benefit-to-risk relationship. Thus, data obtained via research volunteers may be used to provide medical advances or to protect against insidious drugs entering the marketplace. 

Compliance with all these authorities would assist in the approval of drugs for manufacturing and marketing. 

Describe the mechanism for the approval of drugs in China by the SFDA. 

In clinical trials intended to provide sufficient evidence for marketing approval of drugs, what is most important is to collect rmequivocal evidence of a positive risk-benefit profQe relative to an active comparator or placebo. For diseases that are life-threatening or those associated with severe morbidity, it is preferable that the primary endpoint is of clinical relevance, examples being mortality, a measurement of the patient s quality of life, such as rehef of disease-related s)unp-toms, improvement in ability to carry out normal activities or reduced hospitalization time. Unfortunately such trials may need to be very large consequently they tend to have a long duration, and can be extremely costly. 

Despite the efforts of the ICH, the regulatory requirements in the different regions are still quite different. For instance, only the USA has the possibility for accelerated approval of drugs to treat life threatening or severely debilitating illnesses (so-called Subpart E drugs). 

Perceptions of approval of drug-using behaviors in family, work, school, peer, and community environments... 

Donn, Jeff. Zicam Not Alone in Side Effect Reports. ABCNews.com. Available online. URL http //abcnewscom/Health/wireStory id=7863 624. Posted June 17, 2009. Problems experienced by users of Zicam, an over-the-counter treatment for colds, reveal a gap in review and approval of drugs by the FDA, according to this Associated Press article. Since a 1938 law passed Congress, homeopathic remedies have not had to go through the approval process of prescription drugs. This article describes some examples of safety problems that have resulted. In the case of Zicam, the... 

PROMPT APPROVAL OF DRUGS UNDER SECTION 505(j) WHEN PEDIATRIC INFORMATION IS ADDED TO LABELING. 

As a recent study found (Cosgrove et al., 2006), even the development of official psychiatric diagnoses takes place under the sway of the pharmaceutical industry. The Diagnostic and Statistical Manual of Mental Disorders (DSM American Psychiatric Association, 1994, 2000) provides the official diagnoses for use in clinical practice, insurance company reimbursements, basic research, and the FDA approval of drugs. Nearly all the diagnoses are used for justifying the prescription of medications. Of the 170 panel members who contributed to the two most recent editions of the manual, 56% had one or more associations with the pharmaceutical industry. 

Office of Regulatory Affairs (ORA) Releases guidelines for approval of drugs, import licenses, and withdrawal of released products www.fda.gov/ora/... 

The regulatory agencies have so far been on top of these developments. Their dilemma too is that while they can regulate the approval of drugs from trials adjusted to smaller genotypically enriched populations. 

Application for an approval of drug quality control and analytical methods. 

---