Lecture 1 Flashcards
Biologics Control act
Virus-Toxin Law: Granting premarket approval for biological drugs
Pure Food and Drug Act
Truth in labeling, misbranding and adulteration. Labels had to list any addictive or dangerous ingredients
Sulfanilamide tragedy
Diethylene glycol as solvent in sulfanilamide. misbranded as Elixir sulfanilamide and 107 people died. Animal testing was made mandatory
Food, Drug, and Cosmetics act
FDA authorized to also oversee cosmetics. Required animal safety tests, label drugs for safety directions, prohibited false therapeutics claims, truthful drug advertising for therapeutic claims, food packaging and quality control, and mandatory factory inspection.
Durham-Humphrey Amendment
defined two specific categories: Prescription and OTC, pharmacist can refill prescription
Kefauver-Harris Amendment
Efficacy before marketing, advertisement of prescription drugs transferred from FTC to FDA, established GMP, Required advertisement to include side effects, required adverse reaction to be reported to FDA, generic drugs no longer considered break through.
Thalidomide tragedy
thousands of children were born with birth defects due to ADR
Pregnancy Risk categories (before 2015)
Category A (green zone) and Category x (red zone)
Pregnancy risk categories (updated)
Pregnancy, Lactation, and Females and Males of Reproductive Potential
Fast Track and accelerated drug approval
For unmet need or for available therapies that show advantage opposed to whats on the market
Orphan Drug act
For rare diseases and conditions, reduce costs of drug
Drug Policy Reform Act
Refocus the strategies for addressing sbstance use disorder, invest in harm-reduction services, strengthen connections to services, pursue international treaties
General Plan for drug design
Choose a disease choose a drug target Find a lead compound Optimize lead clinical trials Market
What are the factors for choosing a disease?
Epidemiology medical economical social geographical demographical
Safety and tolerability
Phase 1
Phase 2
effectiveness
phase 3
effectiveness and safety
Phase 4
Post-Marketing
Patent Procecss
Patent Analysis Market Trend Target Scouting Assets Valuation Partner Discussion Licensing Deal
