WK1: Advertising, Development, and FDA

pharmaceutical industry

primary driver of new drug development, production and marketing

1.5-5.5

the estimated cost to bring a drug to market is between _._-_._ billion

2

out of every 10 medicines brought to market, _/10 are successful

FDA

government run organization, job is to protect the public in regard to food and drugs

preclinical

phase of drug development with the purpose of determining safety by performing lab studies on nonhuman subjects, timeframe is between 1-4years

phase I

phase of drug development with the purpose of assessing pharmacodynamics, dosages, and pharmacokinetics in a restricted population of healthy human volunteers, timeframe is between 1-2 years

phase II

phase of drug development that assess effectiveness in treating diseases in smaller populations of human volunteers w/ disorder, timeframe is between 2-3 years

phase III

phase of drug development that assesses safety and effectiveness in a larger population of human patients, timeframe is 3-4 years

phase IV

phase of drug development that is the post-marketing surveillance of monitoring for any problems that occur after approval in the general patient population

orphan drug

the ______ ____ act is applied to drugs that treat diseases involving fewer than 200,000 patients in the US, or larger populations in certain circumstances in order to incentivize research and development for rare disease

fast track

accelerated approval pathway that expedites development and approval which leads to accelerated and/or priority review, often done in cases of serious conditions, unmet medical needs, or lack of available treatment

breakthrough therapy

accelerated approval pathway that expedites development and approval in drugs that demonstrate significant advancement over current treatments by establishing fast track status and garnering guidance by senior FDA officials

accelerated approval

process of drugs for serious conditions with unmet medical need being approved based on a surrogate endpoint

priority review

goal of increasing speed of FDA review from 10 months to 6 months, done with drugs showing significant improvement in safety/effectiveness of treatment, diagnosis, or prevention of conditions when compared to standard applications

risk evaluation and mitigation strategy

required by the FDA, risk management plan designed to assure benefits > risks

package insert

piece of paper either attached to bottle or placed in box that has FDA required info about the drug

black box warning

FDA required warning on some products that has a literal box around the warning on the package insert, indicates some form of a significant risk

primary

literature type that includes published research articles, original works, raw data, or other peer reviewed publications

secondary

literature type that includes some review articles, meta-analysis, search engines, and other sources that aid in directing to a primary source

tertiary

literature type that includes textbooks, compendia, full text databases, and other sources that are collections of primary and secondary sources and tend to summarize primary sources

controlled substances

drugs classified according to their potential for abuse/addiction properties

30

supply for controlled substance prescriptions is no more than __ days

CI

controlled substances with very high abuse/addiction risk, examples include heroin, LSD, and marijuana

CII

controlled substances with high abuse/addiction risk, examples include morphine, fentanyl, and methamphetamine

CIII

controlled substances with moderate abuse/addiction risk, examples include dronabinol, ketamine, testosterone, and T3

CIV

controlled substances with low abuse/addiction risk, examples include benzodiazepines and z-hypnotics

CV

controlled substances with very low abuse/addiction risk, such as cough medications and antidiarrheal preparations