Drug Biotechnology Questions and Answers – Controlled Release Medication – Food and Drug Administration in India

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This set of Drug Biotechnology test focuses on “Controlled Release Medication – Food and Drug Administration in India”.

1. What is the other name of the food and drug act?
a) Wiley Act
b) Wily act
c) Will Act
d) Wheel Act
View Answer

Answer: a
Explanation: In June 1906, President Theodore Roosevelt signed the Food and Drug Act which is also known as the “Wiley Act”. Under these acts, all the medical equipment, drugs, foods, food colorants, preservatives, spices, nutraceuticals, pharmacy compounds everything has proper guidelines which should be followed by the manufacturer, retailer, storage, etc.
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2. What is the full form of the FDA?
a) Federal Agency
b) Food and Drug Administration
c) Food and Drug Agency
d) Food Drug Alliances
View Answer

Answer: b
Explanation: Food and Drug Administration or FDA is under the agency of the United States Department of Health and Human Services. FDA gives permission for the marketing of all the medical equipment, drugs, foods, food colorants, preservatives, spices, neutraceuticals, pharmacy compounds, and everything has proper guidelines which should be followed by the manufacturer, retailer, storage, etc.

3. For which of the following FDA is not at all responsible?
a) Foods
b) Radiation-emitting devices
c) Cosmetics
d) Vehicles
View Answer

Answer: d
Explanation: FDA is responsible for the safety regulation of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting products, veterinary products, and cosmetics. FDA is not at all responsible for the manufacturing of vehicles.

4. FDA regulates aspects of prescription drugs.
a) True
b) False
View Answer

Answer: a
Explanation: FDA monitors potential risks of the product, regulate aspects of prescription drugs such as testing, manufacturing, labeling, advertising, marketing, efficacy, and safety. FDA also evaluates marketing applications in a timely fashion. Facilities inspections by FDA are common.

5. What do the Pediatric Rule states?
a) No drug should be tested on children
b) No separate drug for children
c) Include usage of pediatric use of a product
d) Advertise the pediatric usage
View Answer

Answer: c
Explanation: Under the Pediatric Rule introduced in 1998, companies introducing new active ingredients for biologics and drugs, and new dosage forms or indications for existing biologics and drugs, are supposed to assess the effects of the drugs in children and include information about pediatric use of the product in their post-marketing reports.

6. What is meant by Fast Track provision?
a) Send medicines fast
b) Common medicines should reach poor people
c) Rapid approval of priority medications
d) Rapid selling of priority medications
View Answer

Answer: c
Explanation: Under the Food and Drug Modernization Act of 1997 which is also known as the Fast track provisions, the FDA tries to rapidly approve “priority” medications intended for serious illnesses and for which no alternative currently is available. Such as medicines for Alzheimer, cancers, AIDS, Viral infection may get a speedy approval from the FDA and thus can be available in the market as soon as they are approved.
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7. What is the full form of GMP?
a) Good manufacturing provisions
b) Good Monitoring prohibitions
c) Good medical practices
d) Good manufacturing practice
View Answer

Answer: d
Explanation: According to the rules of FDA good manufacturing practice regulations to which the companies must conform in their manufacturing. Products which will not be manufactured in accordance with good manufacturing practice regulations may be adulterated or misbranded and subject to seizure and in the worst cases, these companies can be told to shut down. All the medicines, cosmetics, etc. have different manufacturing guidance which each and every industry is intended to listen to.

8. What is meant by the Good Manufacturing Practice Regulations?
a) Followed by manufacturing companies
b) Only followed by MNCs
c) Followed in the labs only
d) Followed only for cosmetics
View Answer

Answer: a
Explanation: According to the rules of FDA good manufacturing practice regulations to which the companies must conform in their manufacturing. All the drugs, medical equipment, injections, cosmetics, etc, have different manufacturing guidelines according to FDA which should be followed by manufacturing units. Products which will not be manufactured in accordance with good manufacturing practice regulations may be adulterated or misbranded and subject to seizure and in the worst cases, these companies can be told to shut down.

9. What are generic drugs?
a) Drugs for poor people
b) Patented products can be manufactured by other companies once the patent is lost
c) These drugs do not need FDA approval
d) These drugs don’t have specific guidelines
View Answer

Answer: b
Explanation: When new drugs are introduced, they are patented by brand-name drug companies. When these patents get expire, other companies can make drugs using the same active ingredient. These drugs are known as generic drugs. Generic drug companies must submit an abbreviated new drug application demonstrating that their products are bioequivalent to a drug product already on the market. Generic drugs are sold at much lower prices than the original one.

10. What is the full form of OTC?
a) Over the counter
b) Once Treated
c) Over the century
d) Over the country
View Answer

Answer: a
Explanation: OTC drugs are available to consumers without a prescription. Drugs are classified as OTC based on their safety profile, the degree to which their benefits outweigh risks. Such as pantoprazole, paracetamol, etc. These drugs are OTC drugs and are available without a prescription.

11. What is meant by OTC drugs?
a) Drugs which are easy to manufacture
b) Drugs which are available without a prescription
c) These drugs do not need FDA approval
d) These drugs don’t have specific guidelines
View Answer

Answer: b
Explanation: Drugs such as paracetamol, pantoprazole, etc are available without a prescription such drugs are known as Over the counter drugs. OTC drugs are available to consumers without a prescription. Drugs are classified as OTC based on their safety profile, the degree to which their benefits outweigh risks.

12. Which of the following devices are included in Class I devices?
a) Bandages
b) Thermometers
c) Pacemakers
d) Micro ovens
View Answer

Answer: a
Explanation: FDA has different classes of devices such as Class I includes bandages, gloves, Stethoscopes. Class II devices include thermometers and endoscopes. Class III devices include those which come in contact with the body fluids such as that of pacemakers and heart valves.
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13. Which of the following devices are included in Class II devices?
a) Bandages
b) Thermometers
c) Pacemakers
d) Micro ovens
View Answer

Answer: b
Explanation: FDA has different classes of devices such as Class I includes bandages, gloves, Stethoscopes. These have different kind of manufacturing guidelines and practices which should be followed. Class II devices include thermometers and endoscopes which come in contact with the body fluids. Class III devices include those which come in contact with the body fluids such as that of pacemakers and heart valves.

14. Which of the following devices are included in Class III devices?
a) Bandages
b) Thermometers
c) Pacemakers
d) Micro ovens
View Answer

Answer: c
Explanation: FDA has different classes of devices. These have different kind of manufacturing guidelines and practices which should be followed. Such as Class I includes bandages, gloves, Stethoscopes. Class II devices include thermometers and endoscopes. Class III devices include those which come in contact with the body fluids and are kept at that place for a long time such as that of pacemakers and heart valves.

15. Which of the following is not included in Radiological products?
a) Stethoscope
b) X rays
c) Microwave ovens
d) Ultrasound
View Answer

Answer: a
Explanation: Radiological products such as lasers, x-rays and ultrasound machines also may be medical devices are subjected to FDA regulations. Television receivers, microwave ovens, and laser range finding devices, as “radiation-emitting electronic products,” also are subject to FDA regulation. These devices are subject to varying levels of reporting and record-keeping requirements. The radiation-emitting levels are checked by the FDA and are kept under a controllable range.

Sanfoundry Global Education & Learning Series – Drug and Pharmaceutical Biotechnology.

To practice all areas of Drug Biotechnology for tests, here is complete set of 1000+ Multiple Choice Questions and Answers.

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Manish Bhojasia, a technology veteran with 20+ years @ Cisco & Wipro, is Founder and CTO at Sanfoundry. He is Linux Kernel Developer & SAN Architect and is passionate about competency developments in these areas. He lives in Bangalore and delivers focused training sessions to IT professionals in Linux Kernel, Linux Debugging, Linux Device Drivers, Linux Networking, Linux Storage, Advanced C Programming, SAN Storage Technologies, SCSI Internals & Storage Protocols such as iSCSI & Fiber Channel. Stay connected with him @ LinkedIn