Training, physicians

NDA/BLA Review Review is undertaken by FDA staff from different offices within the CDER and CBER. These staff members are trained physicians. 

Following the 1911 revolution, the Ministry of Health of the nationalist government sought to curtail or eliminate traditional Chinese medicine. However, after the communist revolution of 1949, the new government reversed the ban on traditional medicine, establishing a number of traditional medical colleges and institutes whose role is to train physicians and further investigate the uses of herbs. Even in Western hospitals in China, apothecaries are available to dispense herbs upon request. 

As the population increased, the use of patent medicines increased as well. During the late 1800s, few scientifically trained physicians were available, their fees were relatively expensive, and there was a general distrust of their curative procedures (e.g., bloodletting). However, patent products were readily available inexpensive and claimed to be panaceas for many ailments. Unfortunately, the ingredients in these products were not disclosed and many of the products were simply alcohol, water, or flavoring. ... 

Dr. Andrew Weil, a Harvard-trained physician, is the author of several books, most recently Natural Flealth, Natural Medicine. He lives in Tucs on, Arizona. 

At the time, hospitals participating in the FDA effort sent in approximately 3,000 reports each month. One-third of these either lacked key data, or were "impossible to read, code, and analyze. According to FDA officials, better-trained physicians would submit more comprehensive reports "The physician at the bedside must be able to convey on paper for the Food and Drug physician everything he can about drug use, dose and duration of exposure, time of use, and known toxicity. 16 Unlike the broad sweep of patient information collected by the AMA, the FDA reduced data collection to specifics about medications. In particular, the agency focused on the dose and duration of exposure to a particular drug. 

Boerhaave s version of the chemical instruments was a product of the university context. While he acknowledged his debt to the artisanal chemistry of the didactic textbooks, Boerhaave s empirical philosophy, skeptical attitude, and focus on establishing theoretical principles was derived from academic and philosophical traditions. The audience for his courses were medical students, whose future status in the traditional medical hierarchy and republic of letters over that of artisan-practitioners and empirics depended upon their command of philosophical knowledge. The curriculum of the Leiden medical faculty was structured to train physicians for this role, and Boerhaave designed his chemistry courses to accommodate this standard. 

NDA/BLA review Review is undertaken by FDA staff from different offices within CDER and CBER. These staff members are trained physicians, statisticians, chemists, biologists, pharmacologists and other scientists. The FDA may consult with external review committees and experts, but is not bound by their recommendations. 

For many traditionally trained physicians, informal learning about alternative medicines is a sign of the times. This lack of formal professional training in the area of herbal remedies was highlighted in a recent University of Mississippi study, which revealed that 60% of the retail pharmacists interviewed learned about herbal medicines from their patients, and only 25% had learned about them during their professional schooling (Kroll,... 

At present there is very little that can be used to identify individuals with NSAID sensitivity using in vitro tests. Consequently challenges to the patient must be used and in this case only oral challenges are approved in the United States. Such tests are risky and should be performed only by well-trained physicians who are ready to rapidly and aggressively treat a variety of responses including severe bronchospasm, cutaneous, GI, and vascular elfects. 

Many patients in the tropics have diseases that are familiar to Western-trained physicians, but it is the epidemiology that is often different. Comparing the AIDS populations in Los Angeles and Eastern Africa is an obvious example. Different practices in antiviral therapy prescription, distribution, and drug pricing thus emerge in the two environments. 

It is recommended that physicians being trained in this technique perform a minimum of 20 lead extractions as the primary operator under the direct supervision of a qualified training physician. Exposure to the venous entry site, as well as femoral retrieval techniques, should be included. The supervisor should have performed 75 lead extractions with an efficacy and safety record that is consistent with published data. 

Bandages Maintains compression Pressure can be adjusted Recommended for high level of compression (35-80 mmHg) Needs to be applied by well-trained physicians and nurses Pressure variation and no measurement Comprilan , Coban 2 ... 

Stockings No trained physicians required Suitable for low pressure (20-40 mmHg) Difficult to put on Different stockings for different legs Jobst , Sigvaris ... 

The personnel required for insertion of an ICD are very similar to those of the pacemaker implantation. The ICD manufacturer s representative, however, as stated, is controversial. He or she can be an important member of the implantation team and can prove invaluable for providing leads, defibrillators, and support equipment. The earlier ICD implantations that were limited to epicardial placement required a minimum of two trained physicians (an electrophysiologist and a cardiac surgeon). With the transition to the nonthoracotomy approach, a well-trained electrophysiologist working with an ICD manufacturer s representative is frequently all that is required. The ideal constitution of an ICD implantation team is listed in Table 4.1. Each member of the ICD implant team should be completely familiar with the unique requirements of an ICD implantation. This includes a protocol for patient rescue, should it be required. The circulating nurse is responsible for running... 

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