iwewlkws In one of the more severe sentences ever in history for food safety violations, the CEO of the peanut butter company accused of selling salmonella contaminate peanut butter products was given a 28 year sentence for this event. His partner in the company, who is also his brother, was sentenced to 20 years while their quality assurance … Read more
When a non-prescription drug is primarily sold over-the-counter (OTC) and online, the primary regulatory agency is Federal Trade Commission (FTC) and not FDA. FTC monitors advertisement of such products and regulates them under false promotion laws to assure that marketing of such products does not claim more than it should. FTC appealed to FDA to apply same … Read more
Since the passage of Tobacco Control Act in 2009, the FDA has slowly built rules to regulate all forms or tobacco products, from ethnic Bidis to electronic cigarettes. FDA has released 16 rules to date that cover in details the current regulations. Under the Tobacco Control Act, FDA was given seemingly limited powers to assure that the tobacco industry is transparent on … Read more
More than 48 million people (1 in 6 Americans) get food poisoning every year because of contaminated or poor quality food. Foodborne diseases are responsible for about 128,000 hospitalizations and 3000 deaths, many of them infants and children. In Jan 2011, the US Congress FDA passed the Food Safety Modernization Act (FSMA), which gave FDA mandate … Read more
This is the year of drug pricing debate. There are numerous voices to challenge high price charged by manufacturers for life-saving drugs, including introduction of a bill this week in the US Congress to add measures for price control. While political and public opinion appears to be shifting towards reducing the spiraling cost of new … Read more
FDA approval is primarily based on avoiding “false positive” or the Type I error, which means approval of a drug that is ineffective or harmful. FDA review is focused on making sure that all products it approves meet the minimum threshold of being safe and effective. According to a policy paper published by an MIT … Read more
In a news release today, it was announced that England approved its first electronic informed consent. There has been quite a lot of discussion regarding use of electronic or computer-based informed consent in clinical trials. The challenges of these I terms of added cost and time for creating one have not been fully addressed. FDA published … Read more
The European Commission (EC) released an opinion article last week highlighting its expectations on the minimum standards of qualification of GCP inspectors, in particular regarding their education and training. Per the EC, an inspector must have university level education in medicine, pharmacy, pharmacology, toxicology or other fields relevant to Good Clinical Practice principles. In addition, the inspector … Read more
Sponsors have often complained that some divisions at FDA are inherently slower in responding than others. This trend permeates not only the review times for market approval applications but also to clinical trial applications and comment requests. In an article published in Nature Drug Discovery, senior officials at FDA acknowledged that different divisions do have different review … Read more
Since the onset of formal safety and efficacy testing of drugs before their market approval almost 60 yr ago, animal studies have formed the backbone of testing before a given experimental drug can be tested in humans. Supported by principles of ethical clinical research and sound scientific basis, regulators framed laws defining the kind of … Read more
