iwewlkws Much needed major updates to the GCP guidance and the Common Rule were proposed by the FDA and DHHS recently. These changes are being proposed to modernize the regulatory requirements to match the current practices for clinical trials. In one of the most comprehensive updates to the human subject protection rules that apply to clinical trials funded … Read more
The “war” against high drug prices heats up even more this week when in a court filing Federal Trade Commission (FTC) strongly criticized practices used by the pharma companies to keep the drug prices high using questionable business and regulatory practices against generics. Pharma companies use two processes to increase the competitive advantage of their products over … Read more
Two articles in the British Medical Journal this week raise questions about the utility of FDA’s expedited approval programs such as breakthrough therapies and fast-track designations. The articles challenge if in its efforts to approve drugs fast, FDA is being lax in its safety and effectiveness analysis prior to approval. It is obvious from the review that … Read more
Internet pharmacies, mostly located outside of the US borders, are often used by consumers to import drugs into the country illegally. Most of such shipments, which arrive primarily by international mail, are mislabeled as other innocuous things such as dietary supplements, food and cosmetics. And often they are caught at the US customs. Every year … Read more
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
