MPJE Master Federal Pharmacy Law Review Guaranteed Success
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MPJE Master Federal Pharmacy Law Guaranteed
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MPJE Master Federal Pharmacy Law Guaranteed
MPJE Master Federal Pharmacy Law Review Guaranteed
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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...
MPJE Master Federal Pharmacy Law Review Guaranteed
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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
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