Identification and Evaluation of Sources
In source one, this document from a Medicine Journal about the drug, Thalidomide which was developed by a German pharmaceutical company called Grünenthal in Stolberg. This company wanted to create a drug. They started clinical trials for treating respiratory infections in 1956. Researchers at Grünenthal then discovered that thalidomide could help with morning sickness found in pregnant women The drug was then advertised to help with morning sickness in 1957. This drug was found in over 50 different types of over the counter morning sickness medication. This document explains the effects the drug had on pregnant women. Richardson Merrell began testing the drug by distributing 2,528,412 thalidomide tablets …show more content…
Robert Temple, currently head of FDA's Office of Medical Policy..The FOod and Drug Acts was 1906 was the first of a series protection laws enacted by the Federal Government For food and drugs. . Food and Drug Act started to require drug companies to submit safety data to FDA officials for evaluation prior to marketing.THe law used to be that the company releasing the drug would do their own assessment of the drug and then just notified the FDA. Although the new law did not specify any particular testing methods. Under the law, there was no true requirement for FDA "approval" or "clearance" of a new drug. The government had sixty days to complete its safety evaluation. If a company had not received a regulatory response at the end of 60 days it could proceed with marketing its new drug. The value of this document shows how drugs like Thalidomide could be released to the public without proper testing. It shows how a drug could be passed without knowing all the side effects of it. The limitations of the document is that we are unaware of the actually testing that was conducted by the companies. It allows the public to know that drugs were not testing by specific guidelines before being released to the
In source one, this document from a Medicine Journal about the drug, Thalidomide which was developed by a German pharmaceutical company called Grünenthal in Stolberg. This company wanted to create a drug. They started clinical trials for treating respiratory infections in 1956. Researchers at Grünenthal then discovered that thalidomide could help with morning sickness found in pregnant women The drug was then advertised to help with morning sickness in 1957. This drug was found in over 50 different types of over the counter morning sickness medication. This document explains the effects the drug had on pregnant women. Richardson Merrell began testing the drug by distributing 2,528,412 thalidomide tablets …show more content…
Robert Temple, currently head of FDA's Office of Medical Policy..The FOod and Drug Acts was 1906 was the first of a series protection laws enacted by the Federal Government For food and drugs. . Food and Drug Act started to require drug companies to submit safety data to FDA officials for evaluation prior to marketing.THe law used to be that the company releasing the drug would do their own assessment of the drug and then just notified the FDA. Although the new law did not specify any particular testing methods. Under the law, there was no true requirement for FDA "approval" or "clearance" of a new drug. The government had sixty days to complete its safety evaluation. If a company had not received a regulatory response at the end of 60 days it could proceed with marketing its new drug. The value of this document shows how drugs like Thalidomide could be released to the public without proper testing. It shows how a drug could be passed without knowing all the side effects of it. The limitations of the document is that we are unaware of the actually testing that was conducted by the companies. It allows the public to know that drugs were not testing by specific guidelines before being released to the