Law, Rules, and Regulations
This act, passed in 1906, was the first major federal law to regulate drugs and prohibit adulterated or misbranded products?
What is the Pure Food and Drug Act?
This federal agency, which develops and supervises the MMA
What is CMS?
A manufacturer must submit this abbreviated application to the FDA if they want to change a marketed drug's packaging, labeling, or production procedures.
What is a Supplemental New Drug Application (SNDA)?
This FDA Center is responsible for regulating prescription and over-the-counter drugs, including generics and biologics?
What is CDER — Center for Drug Evaluation and Research?
This ammendment restricts government regulation of commerical advertising
What is The First Ammendment?
This 1938 law, passed after the sulfanilamide tragedy, required drugs to be proven safe before marketing?
What is the Food, Drug, and Cosmetic Act (FDCA)?
Medicare Part D is required to include most drugs in these six protected classes
Anticonvulsants, Antidepressants, Antineoplastics, Antpsychotics, Antiretrovirals, Immunosuppressants
This is the minimum number of months the FDA generally takes to review a submitted New Drug Application (NDA), though it can be shortened by Priority Review.
What is 10 months?
What is the key difference between adulteration and misbranding under the FDCA?
Adulteration relates to the drug or facility’s quality/purity, while misbranding refers to false/misleading labeling or inadequate directions
True or False: Ingredients names listed on labels can be brand or generic names listed in the USP/NF
False: generic names from the USP/NF MUST be listed on labels
This term is used when substantial evidence is lacking, and the court has to conduct and entirely new trial
De Novo
This rule requires all prescription benefits programs to accept participation from any pharmacy agreeing to the terms and conditions of their drug plan
What is the "any willing provider clause"?
This is the specific phase of clinical trials where testing is typically conducted at remote sites by independent investigators, making it the most costly and time-consuming stage.
What is Phase 3?
What application must a drug manufacturer file to begin clinical trials and legally ship an investigational drug across state lines?
What is an IND, Investigational New Drug application?
The names of which of the following ingredients are required to be included on the labels of pharmaceutical products?
1. Antimicrobials 2. Coloring agents 3. flavoring oils
Antimicrobials and Coloring agents
This law streamlined the process for grneric drugs coming to market by requiring the ANDA
What is the Hatch-Waxman Anendment or Drug Price Competition and Patent Term Restoration Act.
A plan that wishes to develop its own formulary must have this committee in place, with a majority of its members being practicing physicians and pharmacists.
What is a Pharmacy and Therapeutics (P&T) Committee?
This type of easily measured outcome is allowed as the basis for Accelerated Approval for drugs treating serious conditions, provided it is reasonably likely to predict a clinical benefit.
What is a surrogate endpoint?
This FDA authority can require additional safety measures such as Medication Guides or restricted dispensing programs to ensure a drug’s benefits outweigh its risks?
What is a REMS, Risk Evaluation and Mitigation Strategy
Proposed regulations from the FDA are first published in this
What is the federal register?
This agency handles unfair business practices, antitrust violations, and drug advertising
What is the Federal Trade Commision?
This is the minimum number of days' advance notice a Part D plan must give to the CMS and enrollees before removing a drug from a formulary, unless the drug has a new black box warning.
What is 60 days?
Under the FDA's therapeutic classification system, this numerical designation signifies a new drug that offers significant advancement over present drug therapy.
What is Type 1?
In prescription drug advertising, this law requires that ads contain a “true statement” of information, including risks and benefits, and prohibits misleading or imbalanced claims?
What is Section 502(n) of the FDCA?
This chemical classification indicatesa new therapeutic indication for a drug already approved
What is classification type 6?