Future Regulatory Improvement

Oct 24, 2018 | 0 comments

Oct 24, 2018 | Miscellaneous | 0 comments

Future Regulatory Improvement

Food and Drug Administration oversees regulations concerning food and drugs manufacturing in regard to labeling, packaging and advertising. The laws were drafted in response to increasing innovation in food and drug processing that involved the use of chemicals, most of which are detrimental to human health. This created the need to ensure production of safe, quality and healthy products based on predetermined standards as indicated by Jaffee (2000). Freedom of invention and manufacturing also posed a threat of malicious exploitation of the innocent public by the producers creating the necessity for their protection as well.

The conduct of clinical research regarding has been positively shaped by the FDA’s regulation. FDA has contributed to the ethical standards governing clinical research including laws regulating the use of human subjects with the aim of making sure the trials does not endanger the lives of participants. The ethical standards advocate for voluntary participation with provision of clear closure on the research details to participants in reference to FDA’s freedom of information clause as stated by Amin, McDermott & Shamoo (2008).

The legislation has been invaluable in protecting human health from consumption of sold food and drug products. However, the rules require reviewing and changes where possible in order to meet the demanding changes in the rapidly evolving food and drug processing industries to ensure absolute safety. It is important to clearly define some of the standards governing effective production of drugs and foods as their un-clarity hinders proper implementation of the regulations due to misunderstanding resulting from different interpretation. The agency needs to come up with ways to minimize delays in the validation of new drugs especially that seem to cripple the healthcare sector as recommended by Light (2010).

References

Amin, S.B., McDermott, M.P., &Shamoo, A. E.(2008). Clinical Trials of Drugs Used Off-Label in Neonates: Ethical Issues and Alternative Study Designs. Accountability Research.doi:10.1080/08989620802194392

Frederickson, D. G., & Frederickson, H.G. (2006). Measuring the performance of the hollow state. Washington, D.C: Georgetown University Press.

Gostin, L. O., & Stewart, K. F. (2002).Food and Drug Administration Regulation of Food Safety.

In Lynch, H.F., & In Cohen, I. G. (2015).FDA in the twenty first century: The challenges of regulating drugs and new technologies. New York: Columbia University Press.

Jaffee, I.S (2000). The Food and Drug Administration: An Agency to Protect the Patient and the Physician. Archives of Facial Plastic Surgery. doi:10.1001/archfaci.2.1.62-a

Kondo, J.K., & Product development strategies for foods in the era of molecular biotechnology.Antonie Van Leeuwenhoek International Journal of General and Molecular Microbiology.doi:10.1023/A:1020612405794

Lee, H. (2005). Good Review Practices: The First Step Forward for Korea Food and Drug Administration. Drug Information Journal. doi:10.1177/009286150503900209

Light, D. (2010). The food and drug administration: Inadequate protection from serious risks. In The risks of prescription drugs. New York: Columbia University Press.

Mine, C. (2000). The Food and Drug Administration Modernization ACT and the Food and Drug Administration: Metamorphosis or Makeover? Drug Information Journal.doi:10.1177/009286150003400304

Resnik, D.B., & Tinkle, S.S. (2007).Ethical issues in clinical trials involving nanomedine.Contemporary Clinical Trials.doi:10.1016/j.cct.2006.11.001