FDA history

The use of polymers for biomedical applications has been widely accepted since the 1960 s (7), and specifically for controlled release applications since the 1970 s (2). The primary goal of this research was to create a controlled release matrix from polymers with pre-existing Food and Drug Administration (FDA) histories, which would be capable of releasing insoluble active agents, and upon exhaustion of the device, leave a stable, inert, removable skeleton. The application of such a matrix would be as an intracervical device which would prevent both conception and ascending infection. 

US Food and Drug Administration (FDA) - FDA History. Online. Available HTTP (accessed 1 April 2003). 

FDA (2012) FDA history—part II. The 1938 food, drug, and cosmetic act. http //www.fda. gov/AboutFDA/WhatWeDo /History/Origin / ucm0548261itm. Accessed 17 June 2013... 

Numerous archivists assisted our research, in person or at a distance. They include Dennis Bilger and Randy Sowell of the Truman Presidential Library, Judy Grosberg of the National Cancer Institute Director s Office, Nancy Miller of the University of Pennsylvania Archives, Patrick Shea of the Chemical Heritage Foundation, Brian Shovers of the Montana Historical Society, and Paul Theerman of the National Library of Medicine. Archivists who helped us locate and identify photographs include Barbara Harkins of the NIH History Office, Cindy Lachin of the FDA History Office, Delores Morrow of the Montana Historical Society, Christie Peterson of the Muskie Archives at Bates College, Daniel Whittemore of Sheppard Powell Associates, and Leila Wiles of the Izaak Walton League. We also thank Kate Barry for her help as a research assistant. 

For a more thorough review of FDA history, I recommend Phillip J. Hilts Protecting America s Health The FDA, Business, and One Hundred Years of Regulation (New York Knopf, 2003). 

Recent data suggest that COX-2 inhibitors, including rofe-coxib, valdecoxib, and celecoxib, may increase the risk for MI and stroke.47 There is also some evidence that the non-selective NSAIDs may increase the risk for cardiovascular events.47,48 Rofecoxib was withdrawn from the market in late 2004 because of safety concerns. The FDA requested the withdrawal of valdecoxib from the market in 2005. The FDA also asked the manufacturers of celecoxib and non-selective NSAIDs (prescription and over-the-counter) to include information about the potential adverse cardiovascular effects of these drugs in their product labeling. The cardiovascular risk with COX-2 inhibitors and NSAIDs may be greatest in patients with a history of, or with risk factors for, cardiovascular disease. The American Heart Association recommends that the use of COX-2 inhibitors be limited to low-dose, short-term therapy in patients for whom there is no appropriate alternative.48 Patients with cardiovascular disease should consult a clinician before using over-the-counter NSAIDs. 

Antihistamines such as diphenhydramine are known for their sedating properties and are frequently used over-the-counter medications (usual doses 25-50 mg) for difficulty sleeping. Diphenhydramine is approved by the FDA for the treatment of insomnia and can be effective at reducing sleep latency and increasing sleep time.43 However, diphenhydramine produces undesirable anticholinergic effects and carryover sedation that limit its use. As with TCAs and BZDRAs, diphenhydramine should be used with caution in the elderly. Valerian root is an herbal sleep remedy that has inconsistent effects on sleep but may reduce sleep latency and efficiency at commonly used doses of 400 to 900 mg valerian extract. Ramelteon, a new melatonin receptor agonist, is indicated for insomnia characterized by difficulty with sleep onset. The recommended dose is 8 mg at bedtime. Ramelteon is not a controlled substance and thus may be a viable option for patients with a history of substance abuse. 

Milestones in U.S. Food and Drug Law History, Publ. (FDA) 73-1018, U.S. Dept, of Health, Education, and Welfare, Food and Drug Administration, Washington, DC, 1972. 

Teriparatide is FDA approved for postmenopausal women and men who are at high risk for fracture. Candidates for therapy include patients with a history of osteoporotic fracture, multiple risk factors for fracture, very low bone density (e.g., T-score <—3.5), or those who have failed or are intolerant of previous bisphosphonate therapy. 

In a similar approach to that taken by the FDA, the International Food Biotechnology Council (IFBC) addressed issues associated with food and flavor ingredient production from GM materials and concluded that a reasonable safety assessment could be made by determining whether the ingredient had a prior history of safe use in approved foods and, if so, whether the GM substance was... 

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