Case Study: The Diethylstilbestrol Story
The Diethylstilbestrol Story: An Investigation into the Evolving Public Health Policy for Pharmaceutical Products.
1. What is the pre-approval and approval process pharmaceutical companies have to undergo for new drugs, and what role does the FDA play in mandating safety and efficacy studies for these drugs prior to approval and market release?
New Drugs Pre-Approval and Approval Process Prior to the case of prescription drug, the diethylstilbestrol (DES), pharmaceutical companies needs to get the United States Food and Drug Administration (FDA) approval before releasing new drugs into the market in the United States. These companies need to submit drug’s safety evidence to the FDA for approval and thus indicate the birth of new drug application …show more content…
After the clinical trials on human subject, FDA and sponsors will meet to discuss the post market requirement and obligation just before submitting the NDA. Information about the product’s safety, effectiveness or optimal use is collected by FDA based on the study of post market requirement and obligation (Thaul, 2012). Then, NDA are submitted by the manufacturers to the FDA’s Center for Drug Evaluation and Research (CDER) for marketing approval of the drugs. The NDA contain the result and the analyzed data from both human and animal trials in the pre-clinical and clinical trials. Besides, the NDA also includes the information on how the drug works in the body and the process and facilities involved in manufacturing the drug. Apart from that, NDA contain the product description, indication, labeling, manufacturing description, the quality control and the assurance procedures (Hoff & Chen, …show more content…
These resources also include the common use of medicine, the effect of medicine when driving and also the guideline use of medicine for senior citizen. FDA provides resources that are very useful for consumers and health care professionals such as brochures, articles and slide show presentations. There are several communication channels that were set up by FDA to distribute information about safety and efficacy of prescribed medicine to the consumers, pharmacists and general public such as FDA Drug Safety Newsletter, Drug Safety Communication and FDA Drug Info Rounds (Woloshin et al,
1. What is the pre-approval and approval process pharmaceutical companies have to undergo for new drugs, and what role does the FDA play in mandating safety and efficacy studies for these drugs prior to approval and market release?
New Drugs Pre-Approval and Approval Process Prior to the case of prescription drug, the diethylstilbestrol (DES), pharmaceutical companies needs to get the United States Food and Drug Administration (FDA) approval before releasing new drugs into the market in the United States. These companies need to submit drug’s safety evidence to the FDA for approval and thus indicate the birth of new drug application …show more content…
After the clinical trials on human subject, FDA and sponsors will meet to discuss the post market requirement and obligation just before submitting the NDA. Information about the product’s safety, effectiveness or optimal use is collected by FDA based on the study of post market requirement and obligation (Thaul, 2012). Then, NDA are submitted by the manufacturers to the FDA’s Center for Drug Evaluation and Research (CDER) for marketing approval of the drugs. The NDA contain the result and the analyzed data from both human and animal trials in the pre-clinical and clinical trials. Besides, the NDA also includes the information on how the drug works in the body and the process and facilities involved in manufacturing the drug. Apart from that, NDA contain the product description, indication, labeling, manufacturing description, the quality control and the assurance procedures (Hoff & Chen, …show more content…
These resources also include the common use of medicine, the effect of medicine when driving and also the guideline use of medicine for senior citizen. FDA provides resources that are very useful for consumers and health care professionals such as brochures, articles and slide show presentations. There are several communication channels that were set up by FDA to distribute information about safety and efficacy of prescribed medicine to the consumers, pharmacists and general public such as FDA Drug Safety Newsletter, Drug Safety Communication and FDA Drug Info Rounds (Woloshin et al,