FDA Approval Procedure Assignment Example | Topics and Well Written Essays - 500 words

FDA Approval Procedure - Assignment Example From this paper it is clear that pre-clinical studies must showcase that the medication will not induce chromosomal damage when consumed in potentially effective doses. The results are filed to the FDA together with the IND (Investigational New Drug) application. Apart from the pre-clinical studies report, the IND application contains the information on pharmacologic properties, the proposal for clinical investigations, and clarification of safety measures for prospective volunteers.This essay discusses that after a drug has survived all the trials, an NDA (New Drug Application) is forwarded to the FDA. According to the 1992 Prescription Drug User Fee Act, standard applications are to be reviewed within the 12-month timeframe. Results on priority applications are usually released within six months. Sometimes, FDA may request to provide minor corrections or labeling adjustments. As soon as the product receives the FDA approval, it is allowed for sail. In case of rejection, the FDA pre sents the reasoning together with a list of recommendations. Certain approvals are given under the condition that further research must be conducted shortly after the initial marketing. For instance, the manufacturer may be requested to assess risks in patients with specific illnesses or to examine the long-term effects.  To conclude, drug approval is a lengthy and costly process that is strictly regulated by the FDA.

In What Ways Can Film Be Seen as a Specific Art Form Essay

In What Ways Can Film Be Seen as a Specific Art Form - Essay Example The world is transformed first through the eyes of the director since he is the one visualizing, creating and re-creating a world for the public. Art centers on two ideas: beauty and life. Likewise, cinematic art focuses on aesthetics (the depiction of a portrait to appeal to the senses) and incorporates life images and themes. Through cinema, the author of the film production has the liberty to be unconventional and he can still adhere to the real by embracing a realist approach. improvisation, individual interpretation, reality, illusion, and entertainment of the senses. According to (Gazetas, 2008, 18), â€Å"the  art  of the  cinema  is the  art  of the mind insofar as movies are capable of transforming reality into an object of imagination that completely isolates the viewer from the real world.† Cinema has the ability to transform real objects into imaginative ones and to manipulate lighting, space, and color to explore different themes in-depth. Artists are bestowed with enviable liberties which renders them and their work very flexible. In other words, although the artist aims to give a true-to-life translation of an art piece (an episode in a character’s life), he is free to twist, distort and imagine facts in the real to simulate his own world and orchestrate the course of events. Chris Columbus, through J.K Rowling’s Harry Potter and the Philosopher’s Stone, represents a transformed world which evokes a wonderland of childhood bliss and even  utopia. Set in a child’s paradise Hogwarts School of Witchcraft and Wizardry, one sees through the lens of fantasy, an idealized childhood, illusion, and nostalgia. The possibilities are unlimited, unrestricted from the boundaries of reality. On this stage, the artist makes modifications to the real. Fantasy is the art of infusing the supernatural within the mundane. Columbus as film director fully exploits the power of fantasy in the film, recreating a world in w hich the wizards and witches have constant encounters with the spiritual world. As a result, one sees the intermingling of both imagination and reality in film and in the real world. They do not inhabit separate spheres anymore.