Wednesday, February 19, 2020

Case Study Analysis Assignment Example | Topics and Well Written Essays - 1000 words

Case Study Analysis - Assignment Example of the greatest ironies surrounding the release of the drug into the public domain was that some of the major personnel in FDA such as Merk were aware of the possible threats that were associated with the use of the drug were quite adamant to make it known (Richwine, 2004, November 18). They knew the drug increased risks of heart attack that made it pose as a great threat to public use. However, Charles Grassley one of the primary leaders in FDA initiated research to investigate the risks associated with the use of Rofecobix drug (Topol, 2004). In the course of this research, Dr. David Graham an FDA reviewer discovered the risks associated with the use of the drug, and made a publication without obtaining any clearance from the FDA committee (PhamaLot, 2011, August 28). The primary leadership of FDA has a number of shortcomings most of which contributed to the clearing the drug for public use. The chairperson of the FDA committee Charles Grassley equally raised concern that the relationship that existed between the drug companies and FDA was cozy and, therefore, could not provide room for the establishment of proper control over the drugs cleared (Topol, 2004). Some committee members have also been faulted for knowingly allowing the clearance of the drug and not warning people of the impending risks associated with the use of rofecobix. In addition, when David Graham published his findings, he was faulted by the acting commissioner of FDA, Lester Crawford, stating that Graham did not follow the correct procedures in making publication of his findings report (Richwine, 2004, November 18). Grassley, on the other hand, is on the opinion that Lester Crawford wanted to intimidate, Graham the reviewer and, therefore, his statements were purely meant to i ntimidate the witness before hearing (PhamaLot, 2011, August 28). The above crisis represents a management dilemma, which results into confusion and inconsistency in the nature of research provided. The primary leaders

Tuesday, February 4, 2020

Diffrenece between FAA Regulations (FARs) and UAE GCAA Regulations Essay - 1

Diffrenece between FAA Regulations (FARs) and UAE GCAA Regulations (CARs) - Essay Example The regulations cover all activities of aviation ranging from pilot training to the specification requirements for air craft’s and broader issues that deal with the management of flight operations within a jurisdiction. The general civil aviation authority of the United Arab Emirates bears significant resemblance with the federal aviation administration of the United States. From the onset, it is important to recognize the fact that both of these bodies are regulatory bodies that set the required standards in the field of aviation. The standards that the two regulating authorities majorly deal with broadly concern the requirement of the human resource in the aviation industry and the specifications of aircrafts that are to be used within the jurisdictions that the regulations govern. The GCAA for example is in charge of issuing certificates to aircrafts that have complied with all the safety standards of flying within its airspace, the FAA on the other hand prescribes regulations that govern the standard requirements of safety in all aircrafts in the united states. In dealing with personnel issues, both of the organizations are in charge of the training and certification of the aircraft handlers an d all the people directly involved in the manipulation of the planes (National Aeronautics and Space Administration Staff 1982, pp 613). An international standard is also an area that both the organizations correspond in functional operation. Both the GCAA and FAA provide regulations within their territories to ensure that the aircraft standards and the training of personnel meet the international safety standards that are set for safety and airworthiness (International Business Publications, USA. 2012, pp 227). The major driving force behind these regulations is the safety of all the stakeholders in aviation sector. Through imposing strict standards and regulations in the industry, the chances of accidents occurring through