Drug development and regulation Flashcards
Pure food and drug act (PFDA)
Prohibits mislabeling and adultering drugs
Amendment to PFDA
Prohibits false/fraudulent advertising claims
Harrison narcotics act**
Established regulations for use of opium, opiates, cocaine and later marijuana
Controlled substances act of 1970***
Outlines strict controls in the manufacture, distribution and prescribing of habit-forming drugs;
Establish program to prevent and treat addiction***
Drug Price Competition and Patent Restoration act
Abbreviates new drug applications for generic drugs
Required bioequivalence data.
Patent life extended by time it spends under FDA review
Orphan Drug Ammendment**
Ammends FDCA, provides incentives for development of drugs that treat disease with less than 200,000 pt’s in the USA
Major Legislation pertaining to PR: Ley 11 del 23 de junio del 1976
Creates a board for Bioequivalent for Medications, named by the Secretary of health of PR
Drug development and approval process
Safety tests include: Acute toxicity Subacute toxicity Chronic Toxicity Effect on reproduction Carcinogenic potential Mutagenic potential Investigative toxicology
U.S. Pharmacopeia and Nation al Formulary
Establishes and regulates reference standards
Established by the Food and Drug Act of 1906 (Wiley/Heyburn Act)
Comprehensive drug abuse prevention and control act of 1970
Established the DEA
Established 5 schedules for drugs of abuse
Established penalties for misuse
Established quotas for manufacturing narcotics
Amendment that established the practice of pharmacy
Durham Humphrey Amedment of 1951
- also established pharmacist physician relationship
- Separate class for narcotics and physician registration numbers
- Deals with legen drugs: prescription drugs
Act responsible for premarket clearance for safety and efficacy as well as establishing modern drug review and approval procedures
Kefauver-Harris act
- Requires animal data to be submitted before beginning human trials
- **3 phases of clinical testing
Act that caused review time to be sped up
Prescription Drug User Fee Act: Industry provides FDA funds in the form of fees to pay for positions and resources to review new drug applications
Molecular profile test of a drug
Receptor binding
Enzyme activity
Biotransformation enzymes
Cellular profile tests of a drug
cell culture systems
isolated organ prep