FDA Releasing Information Related to New Fees Required of Human Generic Drug Manufacturers‏

As of October 1, 2012, all firms that manufacture human generic drugs will need to pay user fees to FDA. User fees are fees paid by industry to FDA to help FDA review manufacturers’ products in a timely manner. FDA has issued a number of documents to answer anticipated questions from industry about the program’s requirements and details regarding implementation. These documents also highlight preparatory steps human generic drug manufacturers will need to complete to be in compliance with this new legislation.

For more information, please visit: GDUFA documents

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Early Surgery for Sigmoid Volvulus May be Safe and Effective

August 29, 2012 — Early elective surgery for sigmoid volvulus should be encouraged because it is associated with lower morbidity and mortality, as well as a lower incidence of recurrence, than conservative treatment, according to the findings of a retrospective study. Omid Yassaie, MBChB, from Tauranga Hospital in New Zealand, and colleagues presented their findings in an article published online August 24 in the ANZ Journal of Surgery. The authors remark that the optimal treatment of sigmoid volvulus and the long-term prognosis of patients after treatment are unclear. "Sigmoidoscopic treatment has gained favour as it is less invasive than surgery; however, a significant portion of patients return with recurrent volvulus," the authors write. "There is little, if any data in New Zealand or Australia on long-term follow-up of sigmoid volvulus." The authors analyzed 57 patients (from a total of 84 admissions for sigmoid volvulus) who were admitted to the Department o…

Secondary Prevention: Clinical Approaches to Managing the Higher-Risk Patient with Heart Disease

INCIDENCE/PREVALENCE/BURDENS ASSOCIATED WITH CARDIOVASCULAR DISEASE (CVD) The prevention of an initial and recurrent cardiovascular event and other complications, such as diabetes and kidney failure [also known as end-stage renal disease (ESRD) or chronic kidney disease (CKD) stage 5] is an important goal in patients with a history of CVD. Each year, approximately 185,000 Americans suffer a recurrent stroke, approximately 470,000 will have a recurrent coronary attack, and an estimated 325,000 will suffer a recurrent myocardial infarction.[1] Secondary prevention strategies offer the opportunity to prevent further complications and improve outcomes by early detection and management of common comorbidities. The burden on public health and the costs associated with chronic illnesses such as CVD, CKD, and diabetes remain high. An estimated 82.6 million American adults (1 in 3) have 1 or more types of CVD.[1] Heart failure is the fastest-growing clinical cardiac disease entity in the Unit…

Sexsomnia: Clinical Analysis of an Underdiagnosed Parasomnia

Introduction Sexsomnia, also known as sleep sex or somnambulistic sexual behavior, refers to unintentional sexual behaviors or activities during sleep. Sexsomnia is a relatively new diagnosis. The term was coined by Shapiro and colleagues in 2003,[1] but cases of this condition have been reported in the literature for the past 3 decades.[2,3] Sexual behavior during sleep automatism can range from explicit vocalizations to touching or sexual intercourse, and in some cases even sexual assault or rape. It is non-rapid eye movement (NREM) parasomnia characterized by abnormal transitions between sleep and wake states. The second edition of the International Classification of Sleep Disorders (ICSD-2) discusses somnambulistic sexual activity in the context of disorders of arousal from NREM sleep.[4] Most commonly, NREM parasomnias arise from slow-wave sleep (SWS). Because of a relative lack of cortical control, partial arousals from this deep state of sleep can lead to uninhibited manifesta…

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