FIPP Exam 1 (after stats-present) 100% Verified
drug development process - ANSWER chemistry → nonclinical (preclinical) → clinical →
market
stages of drug development - ANSWER Pre-IND
IND
Phase 1 clinical trials
Phase 2 clinical trials
Phase 3 clinical trials
NDA
Post-marketing
Basic mission of prescription drug regulatory agencies - ANSWER safety, efficacy
(drugs, medical devices), truthful labeling (adulteration, misbranding)
Prescription drug regulatory agency in United States - ANSWER the Food and Drug
Administration (FDA)
Prescription drug regulatory agency in Europe - ANSWER Clinical trial approvals
Germany BfArM
Spain AEMPS
Sweden MPA
Switzerland, not European Union SwissMedic
UK, not an EU member Medicines and Healthcare Products Regulatory Agency, MHRA
,Prescription drug regulatory agency in Canada - ANSWER Health Canada
Prescription drug regulatory agency in Japan - ANSWER Pharmaceutical and Medical
Devices Agency, PMDA
Prescription drug regulatory agency in Australia - ANSWER Therapeutic Goods
Administration, TGA
Prescription drug regulatory agency in South Korea - ANSWER Ministry of Food and
Drug Safety (MFDS)
Prescription drug regulatory agency in China - ANSWER National Medical Products
Administration (NMPA)
How prescription drug regulatory agencies started - ANSWER Early 1900s: you could
get anything you wanted
no concern for people poisoning themselves, few effective drugs, limited rationale for
physician supervision
Harrison Narcotics Act - ANSWER The act passed in, 1914 that made it illegal to sell or
to use opium, morphine, or cocaine in the United States.
Heroin was the hero drug because it saved people from morphine
Where does the FDA get the authority to regulate? - ANSWER Laws passed by congress
CFR (code of federal regulations)
Manual of Policies and Procedures (MaPPs)
,Guidance for Industry
Pure Food and Drug Act of 1906 - ANSWER banned interstate trade of unsafe drugs
mandated proper labeling
defined official drug standard
Federal Food, Drug and Cosmetic Act of 1938 - ANSWER Sulfanilamide and diethylene
glycol disasters
mandated proof of safety
permitted inspections
banned false claims
Durham-Humphrey's Amendment of 1951 - ANSWER Defines a prescription drug
Lists what is a refillable prescription
Kefauver-Harris Amendments of 1962 - ANSWER Thalidomide and birth defects
Mandated proof of effectiveness
Gave FDA control over investigations
Gave FDA authority to regulate advertising of prescription drugs
Establish good manufacturing practices
Orphan Drug Act of 1983 - ANSWER Serious rare diseases affecting fewer than 200,000
patients annually
Includes development incentives for Pharma
Prescription Drug User Fee Act of 1992 (PDUFA) - ANSWER collect user fees from
Pharma to fund the new drug approval process
, FDA required to reduce review time - full approval vs accelerated approval
Food and Drug Modernization Act of 1997 FDAMA - ANSWER 6 months pediatric
exclusivity
FDA Amendments Act of 2007 FDAAA - ANSWER REMS- Risk Evaluation Mitigation
Strategy
SLC- Safety Labeling Changes
Food and Drug Administration Safety and Innovation Act of 2012 FDASIA - ANSWER
Breakthrough therapy designation
FDA Reauthorization Act of 2017 FDARA - ANSWER Encourage pediatric drug
development RACE for Children's Act
Organizations Involved in Drug Development - ANSWER FDA, Sponsors (pharmaceutical
biopharmaceutical companies, academic institutions, other), Contract research
organizations (CROs)
Testing of new drugs for safety and efficacy - ANSWER FDA/CDER does not test new
drugs
sponsors and/or their contractors conduct studies (e.g. non-clinical, clinical, and CMC)
needed to support drug development
sponsors submit study reports to FDA/CDER for review
Pre-IND - ANSWER Define chemical properties of the drug
Conduct nonclinical pharmacology/toxicology studies
drug development process - ANSWER chemistry → nonclinical (preclinical) → clinical →
market
stages of drug development - ANSWER Pre-IND
IND
Phase 1 clinical trials
Phase 2 clinical trials
Phase 3 clinical trials
NDA
Post-marketing
Basic mission of prescription drug regulatory agencies - ANSWER safety, efficacy
(drugs, medical devices), truthful labeling (adulteration, misbranding)
Prescription drug regulatory agency in United States - ANSWER the Food and Drug
Administration (FDA)
Prescription drug regulatory agency in Europe - ANSWER Clinical trial approvals
Germany BfArM
Spain AEMPS
Sweden MPA
Switzerland, not European Union SwissMedic
UK, not an EU member Medicines and Healthcare Products Regulatory Agency, MHRA
,Prescription drug regulatory agency in Canada - ANSWER Health Canada
Prescription drug regulatory agency in Japan - ANSWER Pharmaceutical and Medical
Devices Agency, PMDA
Prescription drug regulatory agency in Australia - ANSWER Therapeutic Goods
Administration, TGA
Prescription drug regulatory agency in South Korea - ANSWER Ministry of Food and
Drug Safety (MFDS)
Prescription drug regulatory agency in China - ANSWER National Medical Products
Administration (NMPA)
How prescription drug regulatory agencies started - ANSWER Early 1900s: you could
get anything you wanted
no concern for people poisoning themselves, few effective drugs, limited rationale for
physician supervision
Harrison Narcotics Act - ANSWER The act passed in, 1914 that made it illegal to sell or
to use opium, morphine, or cocaine in the United States.
Heroin was the hero drug because it saved people from morphine
Where does the FDA get the authority to regulate? - ANSWER Laws passed by congress
CFR (code of federal regulations)
Manual of Policies and Procedures (MaPPs)
,Guidance for Industry
Pure Food and Drug Act of 1906 - ANSWER banned interstate trade of unsafe drugs
mandated proper labeling
defined official drug standard
Federal Food, Drug and Cosmetic Act of 1938 - ANSWER Sulfanilamide and diethylene
glycol disasters
mandated proof of safety
permitted inspections
banned false claims
Durham-Humphrey's Amendment of 1951 - ANSWER Defines a prescription drug
Lists what is a refillable prescription
Kefauver-Harris Amendments of 1962 - ANSWER Thalidomide and birth defects
Mandated proof of effectiveness
Gave FDA control over investigations
Gave FDA authority to regulate advertising of prescription drugs
Establish good manufacturing practices
Orphan Drug Act of 1983 - ANSWER Serious rare diseases affecting fewer than 200,000
patients annually
Includes development incentives for Pharma
Prescription Drug User Fee Act of 1992 (PDUFA) - ANSWER collect user fees from
Pharma to fund the new drug approval process
, FDA required to reduce review time - full approval vs accelerated approval
Food and Drug Modernization Act of 1997 FDAMA - ANSWER 6 months pediatric
exclusivity
FDA Amendments Act of 2007 FDAAA - ANSWER REMS- Risk Evaluation Mitigation
Strategy
SLC- Safety Labeling Changes
Food and Drug Administration Safety and Innovation Act of 2012 FDASIA - ANSWER
Breakthrough therapy designation
FDA Reauthorization Act of 2017 FDARA - ANSWER Encourage pediatric drug
development RACE for Children's Act
Organizations Involved in Drug Development - ANSWER FDA, Sponsors (pharmaceutical
biopharmaceutical companies, academic institutions, other), Contract research
organizations (CROs)
Testing of new drugs for safety and efficacy - ANSWER FDA/CDER does not test new
drugs
sponsors and/or their contractors conduct studies (e.g. non-clinical, clinical, and CMC)
needed to support drug development
sponsors submit study reports to FDA/CDER for review
Pre-IND - ANSWER Define chemical properties of the drug
Conduct nonclinical pharmacology/toxicology studies
