Posts Tagged: FDA

Accounting for Intangibles

Posted by & filed under Accounting Information Systems, Accounting Principles, Advanced Accounting, All Articles, Auditing, Behavioral and Social Issues Related to Accounting, Cost Accounting, Financial Accounting, Intermediate Accounting, Managerial Accounting, Uncategorized.

In a recent meeting, the Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.” Questions:… Read more »

The Coronavirus Testing Procurement Audit

Posted by & filed under Accounting Information Systems, Accounting Principles, Advanced Accounting, All Articles, Auditing, Cost Accounting, Financial Accounting, Intermediate Accounting, Managerial Accounting, Uncategorized.

According to the Washington Post, according to a Maryland state audit, procurement regulations where not followed when the Maryland administration bought 500,000 COVID-19 tests from a South Korean company last year and the first batch of tests that later had to be replaced for an additional $2.5 million was not authorized by the U.S. Food… Read more »

More Easing of the Rules

Posted by & filed under Accounting Information Systems, Accounting Principles, Advanced Accounting, All Articles, Auditing, Cost Accounting, Financial Accounting, Intermediate Accounting, Managerial Accounting, Uncategorized, Video Updates.

More easing of the rules The Food and Drug Administration has temporarily loosened labeling and information rules for food manufacturers for the fifth time during the novel coronavirus pandemic. Questions: Why were the rules eased and what do advocacy groups fear? What rules were eased? According to the article, what type of food disruption have led to… Read more »

Change is coming

Posted by & filed under Accounting Information Systems, Accounting Principles, Advanced Accounting, All Articles, Auditing, Cost Accounting, Ethical Dilemma, Financial Accounting, Fraud Accounting, Income Taxes, Intermediate Accounting, International Accounting, Managerial Accounting, Uncategorized.

Change is coming for a small but blooming corner of the marijuana industry. Questions: 1. What is CBD? 2. Why will regulation change the industry? 3. What are some of the legal grey area with unregulated products? 4. What was the most interesting part of this article for you? Source: Brodwin, E. (2018). There’s a… Read more »

We want REAL eggs!

Posted by & filed under Accounting Information Systems, Accounting Principles, Advanced Accounting, All Articles, Auditing, Cost Accounting, Ethical Dilemma, Financial Accounting, Intermediate Accounting, Managerial Accounting, Video Updates.

Panera petitioned the Food and Drug Administration to update its 40-year-old definition of the word “egg” to exclude most of the processed egg products that have become popular with fast-food chains and food-service. Questions: 1. How long has the egg product rule been on the books of the FDA? 2. Do you agree with Panera?… Read more »

Submarine Patents: What is their Role?

Posted by & filed under Accounting Information Systems, Accounting Principles, Advanced Accounting, All Articles, Auditing, Cost Accounting, Ethical Dilemma, Financial Accounting, Intermediate Accounting, Managerial Accounting.

Humira and Enbrel are biologic drugs, composed of complex proteins made in living cells. Humira was the No. 1 selling biologic with $14 billion in global sales and Enbrel was the No. 3 biologic at $8.7 billion. Questions: 1. Approximately how much is the yearly price tag for these drugs per patient? 2. During the… Read more »

Shkreli Smurks at Congress and Later Calls Them “Imbeciles”

Posted by & filed under Accounting Information Systems, Accounting Principles, Auditing, Cost Accounting, Ethical Dilemma, Fraud Accounting, Intermediate Accounting, Managerial Accounting, Video Updates.

Martin Shkreli, the former chief executive of Turing Pharmaceuticals, repeatedly exercised his Fifth Amendment right to avoid self-incrimination, infuriating members of the House Committee on Oversight and Government Reform. Mr. Shkreli is facing federal securities fraud charges. Questions: 1. What is the scandal that Mr. Shkreli’s company is apart of? 2. What is the connection… Read more »

“A Very Dangerous Process”

Posted by & filed under Accounting Information Systems, Accounting Principles, Advanced Accounting, Auditing, Cost Accounting, Ethical Dilemma, Financial Accounting, Fraud Accounting, Intermediate Accounting, International Accounting, Managerial Accounting.

Specialists in infectious disease are protesting a gigantic overnight increase in the price of Daraprim,a 62-year-old drug that is the standard of care for treating malaria and toxoplasmosis. Questions: 1. What are the causes of price increases for drugs like Daraprim? 2. What is the past controversy associated with Martin Shkreli, the founder and chief… Read more »

Are you getting what is advertised?

Posted by & filed under Accounting Principles, All Articles, Auditing, Cost Accounting, Financial Accounting, Fraud Accounting, Intermediate Accounting, Managerial Accounting, Video Updates.

Four major retailers were accused by the New York State attorney general’s office of selling fraudulent and potentially dangerous herbal supplements. The attorney general demanded that they remove the products from their shelves. Questions: 1. Who were the four national retailers? 2. What were the results of tests performed on the supplements? 3. In summary,… Read more »

FDA Cracks Down on Scary Imports That Impact Public Safety

Posted by & filed under Accounting Principles, Advanced Accounting, All Articles, Auditing, Cost Accounting, Financial Accounting, Financial Reporting and Analysis, Financial Statement Analysis, Fraud Accounting, IFRS, Intermediate Accounting, International Accounting, Managerial Accounting.

India is the second largest exporter of over-the-counter and prescription drugs to the U.S. However, the FDA has recently increased their inspections of these manufacturers due to falsified drug test results, safety lapses, and the sale of fake medicines. Questions: 1. What percentage of U.S. over-the-counter and generic prescription drugs are supplied by India manufacturers?… Read more »