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Since the fungal meningitis outbreak of 2012 linked to contaminated injectable drugs prepared a Massachusetts compounding pharmacy, multiple laws have been passed to regulated compounding pharmacies primarily requiring cGMP compliance and registration with FDA. However, the processes used for compounding are still described in USP monographs. This week, USP announced a much anticipated update to Monograph 797, Pharmaceutical Compounding—Sterile Preparations which … Read more

The US FDA has approved the second implantable medical device for the treatment of symptoms of Parkinson’s disease. The device, Brio Neurostimulation System, provides relief from essential tremor, shaking and difficulty in walking and maintaining balance, that severely affect the quality of life of patients with Parkinson’s. There are several significant regulatory observations that can be made … Read more

This week President Obama announced the appointment of Dr. Robert Califf at the new Commissioner of the FDA. This was no surprise; Dr. Califf had already been acting as the FDA Commissioner since his hiring by FDA earlier this year. Dr. Califf’s major achievement before coming to FDA was creation of Clinical Research Institute at Duke University, which along … Read more

Lots of times, we don’t know what right or wrong is, and lots of times we do. No one takes responsibility for anything anymore. We foster, we obfuscate, and we rationalize. “Everybody does it”, that’s what we say. So we come to occupy a moral safe house, where everyone’s to blame so no one’s guilty. … Read more

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