Agencies And Purposes Of Agencies Flashcards
Which act created the FDA
1906 Pure Food and Drug Act
Main Purpose of the FDA
Consumer protection in regard to food and drugs
FDA protects public health by ensuring the safety and efficacy of what 5 things
- Drugs (vet and human)
- Biologic medications
- Medical Devices
- Cosmetics
- Food supply (supplements fall under this)
Purpose of Center for Drug Evaluation and Research (CDER)
Ensure safe and effective drugs are available to patients without risk (think phases)
In phase 1 trials who is treated
1st time for use in humans. - younger healthy volunteers who may not have the sickness the drug is used to treat
How many people are used in a phase one trial?
A few dozen to no more than 100
What percent of drugs pass through phase 1?
70% move to phase 2
What info is gathered during phase 1
Pharmacokinetics (absorption distribution metabolism and elimination)
Ultimately finding out effects on humans
First phase where drug efficacy is tested
Phase 2
Who gets the medication in Phase 2
Patients who have the disease
How many people in a phase 2 trial
100s of patients but less than 1000
Explain the phase 2 trial
Randomized controlled trials with a control group getting placebo or standard of care
Side effects and tolerability are observed
Monitored for safety and efficacy
How many people in a phase 3 trial
Up to 3000
Where are phase 3 trials conducted
Across the country or across the world (multi centered)
What is the last phase prior to being released to the general public for sale
Phase 3
What specific things are found in phase 3?
- Specific dosing
- Specific indication
- Package insert and labeling for the drug
When is phase 4 conducted?
Post marketing
Who still monitors safety and efficacy during phase 4?
FDA and CDER
How many patients in phase 4?
Tens of thousands or possibly more
In which phase can long term use data be obtained
Phase 4
I’m which pase are rare side effects usually identified
Phase 4
What application needs to be filled out prior to giving a new drug to patients and prior to phase 1 trials
Investigation new drug application (IND)
What application need to be completed prior to selling a drug to the public?
New Drug Application (NDA)
What information is in a new drug application (NDA)
Clinical trial information that the FDA can review prior to approval for sale
What application is submitted to the FDA for approval of a generic drug?
Abbreviated New Drug Application (ANDA)
What is the only thing that needs to be proven in an Abbreviated New Drug Application
Bio equivalence
What is it called when the FDA approves medications to be sold without a prescription?
Over the Counter Approval
2 characteristics of a P drug
- Novel treatment or has advantages over existing treatments
- Will receive special attention and be approved more quickly
Think P stands for priority
2 characteristics of S drugs
- Similar molecule to already approved drug (Me too drug)
- Not in a hurry to approve
Think S for standard
What is right to try legislation?
Allows patients with life threatening diseases to get medications that have made it through phase 1 but have not finished phase 2 or 3 the be approved for sale.
What is responsible for biologic medication approval?
Center forBiologics Evaluation and Research CBER (FDA controlled)
Similar to CDER but for biologics
What application is needed for biologics?
Biologic License Application (BLA)(similar to NDA but for biologics)
What does Medwatch do?
A way for patients consumers and health care professionals to report serious adverse reactions
What 4 things are reported under Medwatch?
- Medications
- Biologics
- Devices
- Dietary Supplements
What form is used by patients and non health care workers to report a Medwatch event?
3500B
What form is used by health care professionals to report to Medwatch?
3500
Is it mandatory to report to Medwatch?
No
Which class of recall is the most urgent
Class 1
What are the risks of a class 1 recall
Immediate danger, death, or serious injury ( very rare)
What are the actions needed from the pharmacy on a class 1 drug recall?
1.Action needs to be taken asap
2. Quarantine drugs
3. Contact patients
What are the risks with a class 2 drug recall?
- No immediate danger
- Risk of injury is possible but unlikely
- Reversible with cessation of the product
Which class of recall does not pose an immediate threat that most likely just does not meet fda regulations but is not harmful?
Class 3 drug recall
What amendment mandated the orange book?
Hatch-Waxman amendment
What is the orange book used for?
Identifies which medications can be substituted
Why would an ab rating have a number after it ie AB1 and AB2
Same drug strength and dosage form, but not bio equivalent ie diltiaZem
In the orange book what does AA mean?
No bioequivalence problems in conventional dosage forms
What is the equivalence rating for an aerosolized solution in the orange book?
AN
What is the equivalence rating for oil solutions in the orange book?
AO
What is the equivalence rating for an aqueous solution in the orange book?
AP
What is the equivalence rating for topical products in the orange book?
AT
What does it mean in the orange book if it starts with a B
The two agents cannot be substituted for one another (not therapeutically equivalent)
The purple book and the orange book are the same except what two things does the purple book contain that the orange book does not?
- It has Biologics
- Identifies biosimilars
What does the Biologics Control Act of 1902 do?
Ensures safety and purity of 1. Vaccines, 2. Serums
