Question#2 THE HISTORY OF FDA REGULATION OF BIOTECHNOLOGY IN THE TWENTIETH CENTU

Question

Question#2 THE HISTORY OF FDA REGULATION OF BIOTECHNOLOGY IN THE TWENTIETH CENTURY

Please read pages 1 -28 of the article entitled, “The History of the FDA Regulation of Biotechnology in the Twentieth Century,” regarding regulation of drugs and biologics.

https://dash.harvard.edu/bitstream/handle/1/8965554/Stepp,_David_00.pdf?sequence=1

Answer each of the questions below . Each of your responses must be supported by information in the article and not from any outside sources unless it is properly referenced and helps to support information found within the article.

A. The 1938 Act provided significant changes to legislation governing new products compared to the 1906 Food and Cosmetic Act. Discuss three examples of the policy changes as a result of the 1938 Act.

B. Overall, what was the goal of the Drug Amendments of 1962 enacted by Congress?

C. What is the difference between an IND and a NDA?

D. What are the five discrete stages of the modern clinical trial process as defined by FDA under the 1962 Amendments? What is unique about each stage?

E. What are cGMPs?

F. What is a "biologic?"

I. Based on what you have read so far, what you would conclude is the overall intent of the FDA?

Explanation / Answer

A. The examples of policy changes as a result of 1938 act are

B. The drug amendments of 1962 decreased the risk of release of misleading or adulterated drugs in the market. It provided FDA with full authorization over the approval for drug manufacturing to the drug releasing processes. Under the 1962 amendmeant production of new-but-unapproved drugs were their violation. The act made it necessary for the manufacturer to obtain a pre approval from the FDA for even the manufacturing of any kind of drugs. It forced the maufacturers to abide by the directives of the FDA for the clinical experiment design or the might risk disapproval by FDA. It ensured that the manufacturer provides demonstration for the effectiveness of a new drug by substantial evidences. However the act left manufacturers with no choice and no manufacturer could market any drug product unless that product and its active and inactive ingredients and methods of manufacture, packaging and labeling were all first approved by FDA as both safe and effective, and then after this pre approval, the manufacturercould not make any significant changes to the products or in the procedure of manufacturing or labeling without further proper pre-approval.

C. IND is investigational new drug application. For the manufacturer to ship the investigational drug to various clinical investigators in other states, it should seek an exemption from the legal requirement. The IND works for exactly the same. It allows the sponsor to techinally obtain that exemption from the FDA. The IND can be proposed for various processes like for proposing to study an unapproved drug, or for authorizing the use of an experimental drug under emergency situation or or clinical testing of drugs for life threatening conditions.

NDA is new drug application. The NDA provides the manufactures with approval of FDA for release and sales of the drug in the market. The documentation under an NDA tells everything about the drug including its contents, results of clinical testings, how it behaves inside the body, its manufacturing, processing and packaging. The NDA provides FDA the overall results that whether the drug is safe and effective, whether the drug's labeling is appropriate or whether the contents and the methods used in manufacturing are adequate.

D. The five discrete stages of the modern clinical trial process by FDA under the 1962 act are-

E. The CGMPs are current good manufacturing practices which have been amended by the FDA. These are procedures for the methods of manufacture of the product. These reflect changes in technology made as per by FDA and also change in any requirements for some special categories of product. The SNDA( supplemental new drug application) requires the manufacturer to submit information about any changes in the product such as contents, manufacturing, processing or packaging. The FDA implies that the SNDA is only approved for the manufacturer if it complies with all applicable CGMPs.

F. A biologic can be referred to any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative which apply for the prevention, treatment or cure of diseases. The control over production of the biologics has also remained under various acts throughout. Before the act of 1902, the production of biologics was not regulated by the federal government. However after an incident of death of thirteen children by antitoxin for diptheria produced from a horse infected with tetanus, lead to to the enactment of the act of 1902 which inhibited the sales of biologics by the manufacturer until the manufacturer had recieved two seperate licenses, an Establishment license and a Product license. After the approval of both these licenses, the manufacturer was further required to submit the biologic product produced along with the testing data and the manufacturer could not begin distribution until a written notice of release is recieved.

I. The FDA focussed on the four standard product areas- 'food', 'drug', 'device' and 'biologic'. The FDA policy evolved historically through the enactment of various acts by the government which increased its involvement as a authority with every new act. The FDA ensured the release of only the safest drugs in the market by acccessing their manufacturing details, clinical procedures and testing results and monitored their safety by post marketing release procedures. It took control over the biologics for releasing only those biologics for human use which passed all the clinical tests and safety measures, once introduced inside the body. The FDA control over the medical devices is much more recent. Like drugs and biologucs, all the devices which were used for diagnosis, mitigation, cure, or treatment of diseases required a pre-approval from the FDA. FDA got the authority for approving the releasing of food products and disapproving it if it does not conforms to the FDA's standards.

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