Q1. What was another name for the Food and Drug Act of 1906? Q2. How is a biolog
ID: 96137 • Letter: Q
Question
Q1. What was another name for the Food and Drug Act of 1906?
Q2. How is a biologic different from a drug?
Q3. What is the connection between the presidents who signed the Food and Drug Act and the Federal Food, Drug, and Cosmetic Act into law?
Q4. What is the Hatch-Waxman Act of 1984? What did it do for new drugs?
Q5. What words did the Food and Drug Act of 1906 define for the first time?
Q6. How many chapters are in the FFDCA? Which ones cover drugs and devices?
Q7. When is a drug or device considered "adulterated"?
Q8. According to the FFDCA, can the FDA regulate drugs that are a part of intrastate commerce? Why, or why not?
Q9. Which section of the FFDCA covers the classification of products?
Q10. Under what conditions is a manufacturer allowed to change the production of an approved drug?
Explanation / Answer
Answer of 1 to 7 are as under:
1. Pure Food and Drug Act of 1906
2. Most biologics are very large, complex molecules or mixtures of molecules. Many biologics are produced using recombinant DNA technology. A drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process.
3. Congress passed the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938 with new provisions. President Roosevelt signed it into law on June 25, 1938.
4. Hatch-Waxman Act of 1984:
Commonly known as “Drug Price Competition & Patent Term Restoration Act” of 1984.
“The Hatch-Waxman Act” is an act dealing with the approval of generic drugs and associated conditions for getting their approval from FDA, patent term extension and Orange Book Listing.”
It is because of this Act that there is the availability of less costly generic drugs into the market without conducting costly and duplicative clinical trials.
At the same time, the brand-name companies (innovators) can apply for up to five additional years longer patent protection for the new medicines that they developed to make up the time lost while their products were going through FDA's approval process.
5. Food and Drugs Act of 1906 First nationwide consumer protection law made it illegal to distribute misbranded or adulterated foods, drinks and drugs across state lines Offending products could be seized & condemned; persons could be fined & jailed Drugs had either to abide by standards of purity and quality set forth in the UNITED STATES PHARMACOPEIA & the NATIONAL FORMULARY Presence & quantity of alcohol or certain narcotic drugs had to be stated on proprietary labels
6. The FFDCA has ten chapters.Chapters 5, cover drugs and devices.
7. According to section 501(b) of the Food, Drug, and Cosmetic Act (the Act) deems an official drug(i.e., a drug purported to be or represented as a drug the name of which is recognized in an official compendium) to be adulterated if it fails to conform to compendial standards of quality, strength or purity.
Related Questions
Navigate
Integrity-first tutoring: explanations and feedback only — we do not complete graded work. Learn more.