FDA
Guidance
implement recommendation and clarify statutory provision
Existing and non existing regulation Guidance Statutory enactment Report/ review of FDA
regulatory science challenge
Statutory enactment
require science-based practice, may need rulemaking, guidance or analysis/support
Preclinical testing
researchers must determine the potential rist for toxicity utilizing in vitro and in vivo studies before testing a drug on people
Clinical research
studies conducted in human to determine the safety and efficiency of a potential drug
Phase 2
Determine efficacy and side effects in patients
dosage and administration
Bases on administration in phase 3
Dietary supplements Bottled water Food additives infant formula
CFSAN regulates food including
Phase 1
Characterize drug in the human safety profile and dosage for Phase 11
Formulation dosage strength route adminstration dosage form device component product line extension
Chemistry and design of a Drug must contain
Terfenadine Cisapride Cervistain
Drugs that have been withdrawn
Science based decision making Leveraging Enforcement transparency
FDA Basic working principles
Phase 1 and 2 before any phase 3
FDA and Sponsors start to discuss drug development
Medical Practice Medical service Price of medical products
FDA does not dictate
Advertising Alcohol Consumer products Drugs of Abuse Health Insurance Meat and Poultry/Eggs Pesticides Restaurants and grocery stores water
FDA does not regulate
Regulation tobacco products Helping to speed innovations that make medicine and food more effective/safer Helping the public get accurate information they need to use medicines and food
FDA is also responsible for advancing the public health by
Bioterroism Flue Food pathogens antibiotic resistance Bis-phenol A Drug re-importation Counterfeit drugs Gene therapy Hormone replacement therapy stem cell research personalized medicine biomarkers
FDA issues
Protect and promote the public health Consumer protection agency Regulatory agency
FDA mission
Bulk maufacturing Packaging Labeling Quality controls
Manufacturing and controls of a drug contains
Responsible for protection of consumers by ensuring compliance inspection of regulated products
ORA does what
Discovery and screening
Researcher discover a potential drug candidate and preform preliminary test to evaluate and characterize the drug
Food Drugs Dietary Supplements Vaccines/ Blood Animal Food and Drugs Biotechonolgy toxicological research Medical Devices/ Radiology Cosmetics Tobacco products
Scope of FDA's Mission
assure that proposed human trial do not place humans at unreasonable risk verifies sufficient informed consent verifies human subject protection
What does the FDA review of the IND
Chemical structure proposed method of action preclinical work an anticipated side effect any issue with manufacturing Detailed clinical plan
What is an IND
Existing and non-existing regulation
adapting to considering new scientific methods may mean new rule making
adverse reaction
based on events reported in all clinical studies
clinical efficacy
based on the outcomes of phase 3
Phase 3
confirm efficacy and monitoring of adverse reaction
clinical pharmacology
mechanism of acition, pharmacodynamic, pharmacokinetics from phase 1 and 2 studies
indication
patient population and disease tested
Serious disease unmet medical need surrogate endpoint rolling submission
what can happen with and accelerated approval
Stop the trial at anytime must receive regular updates side effects negative results highly positive results
what can the FDA do in clinical trials
Advances regulatory science research Promotes global interactions fosters scientific training
what does NCTR do
FDA has 60 days CDER team is assigned to review FDA inspects manufacturing site one year for a new drug review
what happens when NDA is submitted
sponsor submit periodic updates monitor for side effects
what is a post marketing safety system
Multiple species of animals must be tested IND submitted to FDA FDA review within 30 days IND is open and in effect
what is done before clinical trials can start
All materials from IND Additional non-human studies since IND all human data How drug behaves in the body Drug chemistry, manufacturing and controls
what is the NDA
meets with sponsor before NDA is submitted
what must happen before NDA is submitted
CDER sponsor Team of scientist Physicians Biochemist statisticians pharmacologist......
who evaluates the NDA