iwewlkws One more survey makes bold claims regarding the risks of dietary supplements, particularly those of herbal origins. In a report published in the New England Journal of Medicine this week, researchers from CDC and FDA made an estimation of emergency room visits to more than 23000 each year which are linked to consumption of dietary supplements about … Read more
Since the passage of the Compounding Quality Act in late 2013, compounding pharmacies have had a rough experience trying to comply with tough GMP rules. Of the almost 60 compounding pharmacies that voluntarily registered with the FDA, almost 50 have gone through FDA’s audit for GMP compliance and all but one were found to be in significant GMP violations and … Read more
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
