Kefauver-Harris Amendment Essay Example | Topics and Well Written Essays - 500 words

Kefauver-Harris Amendment - Essay Example 127-128). The communal protest caused by the Thalidomide calamity near the beginning of 1960s hastily directed to the road of new set of laws and an unusual sentiment regarding untried drugs. In an attempt to stop happening one more analogous tragedy at the rear of the Thalidomide mishap, the U.S. Parliament, in 1962, passed the Kefauver-Harris Drug Amendment, ordering austere controls on drug checking, promotion and selling. The edict asserted for the first time that hottest drugs must be made known to be helpful before being advertised. In addition, it proposed stringent regulations for sound engineering practices, the intention being to augment quality control in the manufacturing route. The new codes would step up to transform not only the approach Americans participated in drug experiments but also their anticipations for the safety of drugs approved by the U.S. Food and Drug Administration. Kefauver-Harris Drug Amendment conceded collectively by the Congress to strengthened control over recommended and unproven drugs and to make certain greater drug protection. It was acknowledged that no drug is actually harmless unless it is also effectual. Before publicizing a drug, its manufacturers now had to demonstrate to FDA not just safety, but also provide considerable verification of effectiveness for the product's future utilization -- a milestone proceed in medical record.

Critical Reflection Pieces Essay Example | Topics and Well Written Essays - 750 words

Critical Reflection Pieces - Essay Example Good theories predict the unknown. After reading the Cybernetic in the Dialectic between Science and Design, it was realized that the perspective of the designers and the scientists was different. The Scientists based their arguments on observations, while the designers based their arguments on innovations. The designers created something that is yet to be observed and measured. Additionally, the scientists celebrated the aspect of generalization for instance on abstract theories, the designers on the other hand proposed artifacts that must result to operating in their details rather than their abstract. Reflecting on the content of the paper, the scientists insisted on the causal explanations. They excluded themselves from the causes of phenomena that they explored. The designers intended to cause something out of their own actions. The contrast between the designers and the scientists was evident. For this reason, the author adopted a less philosophical commitment in defining the term cybernetics. Based on his defi nition, he termed it as study of the possible systems, which resides on what that cannot be build or evolved in nature. Therefore, majority of the authors work is characterized as exploring the difference between innovation and observation (Krippendorff, 2007). After reading the 2nd order Cybernetics and Human-Centeredness, it can be reflected that the section only mentioned artifacts but not objects. The artifacts arose in the coordination of sensory motor as they are developed by those accounted and involved for their deeds under conditions with reliable interactions. For this reason, what people normally call objects can also be artifacts because they are also crafted skillfully. Artifacts might come from designing a material through recognition and in interfaces, which can be differentiated based on their interactivity. According to their interactions, it can be said that the meaning are less subjective.