Federal Part 1 Flashcards
What is the the FDA responsible for?
Protecting the public health by ensuring safety, efficacy, and security of drugs, biologics, and med devices
How many centers are in the FDA?
6
According to the US pharmacopoiea, what is a drug?
Substances intended for use in diagnosis, cure, prevention of disease in people or animals
Is soap a cosmetic?
No
What is the definition of dietary supplement?
Substances used to supplement diet by increasing TDI
Who is involved in pre-clinical testing?
Animals to determine therapeutic use
What is the First application form submitted by the sponsor to the FDA before the drug can be administered to humans?
Investigational New Drug
* FDA permission for phase 1 trials
Purpose for IND?
- Safety in humans
- Proper design of studes
- COnduction of human trials
Once the IND has been submitted, the FDA has ___ days to decide if the drug is suitable for testing?
30
What do phase 1 trials assess
Safety of drugs in humans
Several months
What does phase II trials assess?
Safety and efficacy
Several months - 2 yrs
What is assessed in phase III trials?
Effectvieness compared to a control group recieving a placebo
Years
How many subjects are in a trial
PI: Small number of healthy individuals
PII: 100+ with dx
PIII: 300-1000 patients
Who is responsible for conducting clinical trials?
PI: sponsoring company
PII: sponsoring company
PIII: Idependent investigators at clincal sites
What phase determines dosage range?
Phase 1
What phase is a blinded study
Phase 2 and 3
What phase obtains info about adequate dosage and ADRs?
Phse 2
Drug that is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug’s labeling
New drug
The FDA has ___ days to act on a new drug application
180 days
* most apps are reviewed within 10 months
Median review time was reduced to 15 months
What is the BLA?
New drug application for biologics
What is the FDA expedited review program?
Reduces a drug’s FDA review period from ten months to six (both NDA and BLA)
What is a fast track?
Drugs intended to meet unmet med needs without treatment existance or drugs that offer substantial benefits over existig treatments
Drugs must show early clinicalevidence of substantial improvement over existing therapies
Breakthrough therapy
Intendedfor drugswith long-term endpoints, such as increased survival or decreased morbidity, which are difficult to measure efficiently in trials
Accelerated approval
How can an approved drug be considered new? What is the application called?
- New substance
- New comboniation
- Proportion of ingredients
- New intended use
- Changes in dosage, method, and admin
Supplemental New drug app (SNDA)
How long is the exclusivity of SNDAs?
3 yrs
Generic drug approvals?
- ANDA
- 505(b)(2) application
Does ANDA hrequire studies?
Not pre or clinical studies, but must provide data comparing to branded drug
Generic drug requirements?
- Same active ingredient
- Same route
- Same dosage form
- Same strength
- Bioequivalent
- Inactive ingredients can be different
What is the 505 b 2 app?
Drug can be marketed in different strength or fomulation than the branded
First applicant to complete a formal review showing bioequivalence to brand product granted ____ of exclusivity
6 months
Approved Drug Products with Therapeutic Equivalence Evaluations
Orangebook
What is the TE codes?
A: therapeutically equvalent
B: not therapeutically equivalent
Second letter describes dosage form or nature of product
Used to assist healthcare professionals with interchanging biosimilars
Purple book
What is the purple book coding system?
B: biosimilar (can’t be substituted for reference product by pharamacist without PA)
I: interchangeable (can be subbed without prescriber intervention)
Will unapproved drugs appear in the orange book?
No, but will have an NDC
What is Phase IV trials
Used to obtain long-term safety and efficacy
* New uses and abuses
* Post marketing surveillance
How often are manufacturersrequired to submit post-market surveillance?
Annually
Voluntary reporting system that allows healthcare professionals to report ADRs, errors, and quality problems?
MedWatch
MedWatch is exclusive to prescribers
No, FDAAA brodened it to include patient and consumer reports
How often are ADE required to be reported by the manufacturer?
Quarterly for first 3 yrs after approval, then annually
WHat is REMS?
Used for drugs that have high potential for harm:
* Special training
* Specific dispensing settings
* Patient enrollment and monitoring
Provides FDA-approved patient-friendly labeling of ADRs, directions, and risks?
MedGuide
Does the FDA directly communicate the risks of REMs to the patient?
FDA approved materials -> Healthcare providers -> Patient via communication plan
Requires medical interventions or other actions by healthcare professionals prior to prescribing or dispensing the drug
Elements to assure safe use (ETASU)
Ex: dispensig naloxone with fentanyl
When is an implementation system used?
Severe ADRs, limiting distribution or access program for the drug:
* Open distribution
* Managed distribution
* Controlled distribution
* Restricted access
Drug product may cause serious adverse health consequences including death
Class 1 recall
Drug product may cause temporary or reversible effects
Class II recall
Drug product is unlikely to cause any adverse health consequences
Class III
Manufacturers must notify the FDA ___ days prior to withdrawing a product from sale
180
Who regulates prescription drug ads?
FDA
Who regulates OTC ads?
FTC
Does advertisements need to be approved by the FDA?
No, but will get involved if there has an ad of fallse and misleading information
Ads must include:
- Name (brand an generic)
- At least of one FDA approved indication
- Most significant risks
Implemented in 2010 to enlist healthcare professionals to help ensure that company promotion of prescription drugs is truthful
Bad Ad program
Customer benefits of drug ads?
- Education
- Awareness
- Compliance
- Lowers drug prices
Pharmacist benefits of drug ads?
- Increase Rx bus
- Greater public recognition
COns of drug ads?
- Raises health care
- Inappropriate demand of drugs
- Confuse patients
- Jeopardize patient-physician relationship
How should drug ads be advertised in pharmacies?
- Price
- Propetary name of the drug
- Established name
- Strength
- Dosage forms
- Price chargerd
