MPJE Master Federal Pharmacy Law Review Guaranteed Success

MPJE Master Federal Pharmacy Law Review Guaranteed Success The most important agency within the federal government when it comes to approving companies to market and sell their drugs to the public ️️Food and Drug Administration (FDA) -Involves giving the drug (or medical device) to humans for the first time -Given to a small number of healthy volunteers (do not necessarily have the disease that the drug is intended to treat) -Important for gathering what effects the drug will have on humans (pharmacokinetics) ️️Phase 1 Clinical Trial -First time that a drug's efficacy is tested in humans -Given to patients who have the actual disease ️️Phase 2 Clinical Trial -Large clinical trials that often encompass up to 3,000 patients -Trials can be done across the country/world -Monitor the new drug for safety and efficacy -Final phase prior to approval of the drug for sale to the general public -Identify specific dosing and indication ️️Phase 3 Clinical Trial -Often referred to as Post-Marketing Surveillance -Drug is being used in clinical practice ️️Phase 4 Clinical Trial Asking for permission to give a new drug or product to humans (prior to phase 1 clinical trial) ️️Investigation New Drug (IND) Application -Seeking approval of a new drug to be able to sell the drug to the general public -The drug company or sponsor presents clinical trial information to the FDA for potential approval for sale ️️New Drug Application (NDA) -Approval process for a generic medication -Bioequivalence is the only thing that needs to be proven ️️Abbreviated New Drug Application (ANDA) What types of drugs are more likely to get approval for fast track designation? ️️Drugs that treat a serious or lethal condition and it is a novel agent that meets a need that has not been met by currently available FDA approved agents -FDA chooses this classification when a drug is a novel treatment or has advantages over existing treatments -This type of drug will receive special attention and be approved more quickly ️️P drugs This classification is selected by the FDA for drugs that have a similar molecule to an already approved FDA drug ️️S drugs Legislation that allows patients with life-threatening diseases or conditions who have tried every FDA approved agent to utilize agents that have made it through Phase 1 testing, but are not currently approved ️️Right to Try Legislation Institution responsible for the approval of biologic medications ️️Center for Biologics Evaluation and Research (CBER) Helps ensure safety of medications by allowing patients, consumers, and healthcare professionals the ability to report serious adverse reactions or problems with medications, biologics, devices, or dietary supplements ️️MedWatch Form 3500B can be utilized by: ️️patients and non-healthcare professionals to report adverse effects Class 1 Drug Recall ️️-Highest risk, most urgent -Possibility exists for immediate danger, death, or serious injury Class 2 Drug Recall ️️-No immediate danger -Risk of injury is possible, but unlikely to be serious -If injury or adverse effects occur, they will most likely be temporary or reversible Class 3 Drug Recall ️️No immediate danger with the use of the product -A formal list of all FDA-approved drugs including OTCs -Used to identify which medications can be substituted for one another ️️Orange Book Book used used to identify agents that are considered to be biosimilar agents ️️Purple Book Legislation that ensured safety and purity of vaccines, serums, and products that were used to treat or prevent diseases ️️Biologics Control Act of 1902 Legislative that prohibited interstate commerce of misbranded and adulterated drugs ️️Food and Drugs Act of 1906 (Wiley-Heyburn Act) Legislation that forced new drugs to be proven safe before marketing; Also required labels to include adequate directions for use and warnings about habit-forming drugs that were contained in products (first law that applied to cosmetic and medical devices) ️️1938 Food, Drug, and Cosmetic Act Legislation that defines which drugs can and cannot be safely used without medical supervision and requires that a patient have a prescription from a licensed practitioner before being allowed to purchase certain medications (OTC vs Rx) Also allowed for oral prescriptions and refills of prescription drugs; subjected drugs to the NDA approval process ️️Durham-Humphrey Amendment of 1951 Legislation that ensures efficacy (first time ever) and enhanced drug safe