PracticeLink Magazine

Summer 2019

The career development quarterly for physicians of all specialties, PracticeLink Magazine provides readers with feature articles, compensation stats, helpful job search tips—as well as recruitment ads from organizations across the U.S.

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Page 34 of 83

R E F O R M R E C A P S UMMER 2019 35 OPPORTUNITIES Cardiology-General, Endocrinology, Emergency Medicine, Family Medicine, Gastroenterology, Hospitalist, Internal Medicine, Internal Medicine-Pediatric, Nephrology, Neurology, Orthopedics- Surgery-Spine, Pediatrics, Psychiatry, Pulmonary Critical Care, Surgery- General, Surgery-Neurological CONTACT MegAnne Townsend, Physician Recruiter White River Health System Batesville, AR 72501 Local: (870) 262-6545 Fax: (870) 698-0950 YOUR FUTURE AWAITS. YOUR CAREER AWAITS. YOUR ADVENTURE AWAITS. Arkansas White River Health System is a regional healthcare organization serving a ten-county area of more than 110,000 that includes Batesville, Mountain View and Cherokee Village, Arkansas. Here you'll find a fulfilling career and a lifestyle well-suited to those who enjoy outdoor activities. The area offers an affordable cost of living, quality school systems, and residents with a friendly, welcoming nature. The Fast Track program is one of four related processes for expedited review of certain categories of drugs. Lists of approvals for New Drug Applications and Biologic License Applications are available at Balancing speed and safety Although getting new drugs to market promptly is desirable, the process must be balanced with the need for safety. The archetypal case of the need for caution is Thalidomide, which was used to treat nausea and difficulty sleeping in the 1950s and 1960s. Thalidomide was widely used in Germany, but a drug reviewer for the FDA did not approve its use in the u .S. out of concern that there was not enough evidence about the drug's safety. Thalidomide caused approximately 10,000 children, mostly in Europe, to have severe congenital deformities (phocomelia). More recently, in 2012, Ponatinib was granted Fast Track status for treatment of chronic myeloid leukemia (CM l ). Within one year, the drug was found to cause a high frequency of serious adverse vascular events. Approval of Ponatinib was withdrawn, although it was later reintroduced for a much narrower class of patients for whom there were no alternative treatments. 4 processes for expedited review The FDA says it attempts to review all drugs efficiently, but "gives special consideration to therapies that treat serious or life-threatening diseases or have the potential to provide unusually large benefits to patients." There are four processes to speed development of drugs. They can be used individually or in combination: 1 FAST TR ACK. Added opportunities for drug companies to meet with the FDA; rolling review of applications (review of portions of applications before entire application is complete). 2 PRIORIT Y RE VIEW. r educes the FDA review period from 10 months to six months. 3 ACCELER ATED APPROVAL. Intended for drugs with long-term endpoints, such as increased survival or decrease in morbidity. Accelerated Approval allows surrogate endpoints that are reasonably likely to predict clinical benefit (e.g., reduction of viral load or tumor shrinkage for some types of cancer). The efficacy of the drug must be confirmed in post-market trials. If the post-market trials do not verify efficacy, approval may be withdrawn. 4 BRE AK THROUGH THER APY. Generally reserved for drugs with substantial evidence of improvement over existing therapies. The application for this designation usually is made no later than the end of the drug company's Phase-2 meeting with the FDA. Breakthrough therapy designation is similar to Fast Track with greater emphasis on early meetings and coordination with senior FDA personnel. Source: FDA

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