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Similarly, Anika Therapeutics' Monovisc single-injection hyaluronic acid (HA) viscosupplementation product, which had been awaiting FDA approval since 2009, received nonapproval in December 2012.
So in most instances it should not be difficult to make an objective assessment as to whether or not a particular fact or intervening circumstance would suffice, in the normal course, to cause prosecutorial withdrawal or judicial nonapproval of a plea bargain.
However, most insurance determinations leading to nonapproval for undertaking a medical procedure or surgery will ultimately coerce the consumer to forsake the procedure or surgery.
Were this new agency to be created, it would effectively create within the FDA an anti-drug entity with strong incentives to argue for the nonapproval or withdrawal from the market of drugs that have significant side effects even if they offer huge net benefits.
Genta responded that nonapproval would be a denial of patient access to Genasense[R] because they could not afford to give it away in an expanded access program.
Goodman claims that Buddhists deny all notions of moral responsibility, and that this supports their nonapproval of emotions such as anger and resentment at certain actions; for no one is seen as actually responsible for them (366).
Other information that has surfaced along the way strengthens the inference that the presumed inability of younger women to use Plan B correctly was a smoke screen (or, perhaps more appropriately, a "fig leaf") used to obscure the real pressures for nonapproval.
The panel recommended nonapproval, however, citing concern about differences between Sweden and the United States in labor management and medical terminology.
The economic impact of subdivision approval or nonapproval on the value of a property was significant.
Among the eight therapies in development that were profiled in the research, interest is rated highest for Novartis's Gilenya and Merck Serono's Movectro -- despite the recent nonapproval by the European Medicines Agency for the latter product which Merck has recently appealed.