FDA infograph, video, article

Question 1

CDER

Answer 1

staff is committed to protect public health and regulating human drugs. They analyze data and evaluate research to ensure RX, generic, and OTC are working correctly.

-benefits outweighs risk ?
- new drug safe?
- work the way it suppose to?

CDER- provides patients and doctors the information they need to use medication wisely

Question 2

FDA DOES NOT (3 things)

Answer 2

Yes they oversee clinical trails

-They DO NOT conduct clinical trails

-They DO NOT control cost of drugs

• DO NOT influence patient care

Question 3

drug developed

Answer 3

drug sponsor develops new drug and seeks it to be approved by FDA for sale in U.S.

Question 4

animal tested

Answer 4

sponsor tests drugs on animals for toxicity

250 animals

collect info on safety and efficacy

Question 5

IND Application

Answer 5

sponsor submits a IND to FDA in results of the initial testing:

drug composition and manufacturing and developing a plan for testing drug on humans

Question 6

IND Review

Answer 6

FDA reviews the IND, to ensure that the clinical trials (proposed) do not present any threat to human subjects, ensures that there is informed constent and human subject protection

Question 7

PHASE 1

Answer 7

100 healthy volunteers
emphasizing safety

• determine side effects and metabolism and excretion

Question 8

PHASE 2

Answer 8

200-300 people
emphasizes the safety and mostly effectiveness.

does the drug work in a certain disease condition ?

Question 9

PHASE 3

Answer 9

it only begins if evidence of effectiveness is shown in phase 2

1000+ people and they gather information on safety and effectiveness

different populations and different dosages, and uses drugs in combination of other drugs

Question 10

NDA Review

Answer 10

1. Drug labeling: FDA reviews the drugs professional labeling and assures appropriate info is communicated to healthcare professional and consumer.
2. Application reviewed: FDA has 60 days to decide whether to file it so it can be review. FDA will evaluate the SAFETY AND EFFICACY
3. NDA application: includes all of the animal and human studies and how the drug behaves in body and how it is manufactured

4.NDA Meeting: fda meets with sponsor prior to submission of NDA.

5. Faculty inspection: FDA inspect the manufacturing place where drugs are made
6. FDA approval: FDA issues a response letter or approve drug

Question 11

POST MARKETING

Answer 11

unexpected ADR

Sponsor needs to submit periodic updates

MEDWATCH- makes it easier for physicians and consumer to report issues or ADRs of the drug, if new indication’s it will change the labeling and new reports are issued about the changes to the public.

Question 12

Prescription Drug User Fee Act (PDUFA)

Answer 12

1992 (1000+ drugs and biologics) it has enabled FDA to Bring access to new drugs faster than anywhere in the world. Under this act, frug companies agree to pay a fee to boost FDA resources and FDA agree to time frames for the review to drug application