Exam 1 (Lectures 3 & 4) Flashcards
What three things did the 1906 Pure Food and Drug Act?
- Recognized U.S. Pharmacopeia and the NF as standard drug references
- Defined misbranding and adulteration and assigned penalties
- Established FDA as responsible party for enforcement
Class I devices + examples
not used for supporting human life
i.e. stethoscope
Class II devices + examples
moderate risk to use
i.e. MRI, CT scan
Class III devices + examples
high risk to use, supports or sustains human life
i.e. prosthetic heart valve
What did the 1912 Sherley Amendment prohibit?
Prohibit manufacturers from intentionally misleading claims about a drug effectiveness
1938 Federal Food, Drug, and Cosmetic Act
-Required new drugs to be shown safe before marketing
-Repealed Sherley Amendment
-Authorized factory inspections
-Required select drugs to be administered under the direction of a qualified expert
1951 Durham-Humphrey Amendment
- OTC meds could be labeled with “adequate directions for use”
- Legend meds had to be dispensed under the supervision of a health practitioner as a prescription drug and include the statement “Caution: federal law prohibits dispensing without a prescription
- Allowed verbal transmission of Rx and refills
1962 Kefauver-Harris Amendment
- Required medications to be demonstrated not only safe, but also effective
- Transferred jurisdiction of Rx advertising from FTC to FDA
- Established current good manufacturing practice (cGMP)
- Added requirements for clinical investigations including informed consent of subjects and reporting of ADRs
cGMP requires any manufacturer for drugs used in the United States must be….
registered with the FDA and undergo an inspection at least once every 2 years
If you don’t comply with cGMP, the product is ____________
adulterated
If you don’t register with the FDA, the product is….
adulterated and misbranded
Which of the following does not need to follow cGMP?
1. Pharmacy/traditional compounding (503a)
2. Outsourcing facilities (503b)
3. Manufacturing
503a
DESI drugs are medications approved between _____-______ based only on safety
1938-1962
Step 1 of Drug Discovery Process:
What is preclinical research used for?
in vivo animal testing is used to record data on toxicity and pharmacology of the product
Step 2 of Drug Discovery Process:
What must an investigational new drug (IND) application include?
- animal pharmacology and toxicology studies
- manufacturing information
- clinical protocols and investigator information
Step 3 of Drug Discovery Process Clinical Phase I:
What is evaluated in clinical research phase I?
-safety and dosage of compound
-baseline human PK properties
Step 3 of Drug Discovery Process Clinical Phase 2:
What is determined in this step?
effectiveness of therapy
Step 3 of Drug Discovery Process Clinical Phase 2:
How many patients?
< 1000
Step 3 of Drug Discovery Process Clinical Phase 3:
What is the goal?
demonstrate efficacy at a higher power and expand information around adverse effects
What is step 4 of the drug discovery process?
New drug application (NDA) is submitted to FDA
Step 5 of Drug Discovery Process: Post-marketing surveillance (Phase 4):
What is reviewed and by who?
FDA reviews MedWatch for trends among adverse events report by health professionals and patients
1983 Orphan Drug Act
incentivized companies to develop drugs for rare diseases
1984 Hatch-Waxman Act
was passed to reduce the requirements for approval of generic prescription drugs and generic companies can prepare for approval without impinging on patent
What is an abbreviated new drug applications used for?
generic drug approval - applicant does not need to include animal and human clinical trial data to establish safety and efficacy
