iwewlkws This week FDA released a Warning Letter* issued to a GMP vendor in India that points to a very important issue that all companies using vendors, specifically foreign vendors, should be aware of, namely, who is listed as the manufacturer on the Certificate of Analysis (COA). Is the vendor being truthful about its sub-vendors and … Read more
Clinical trial populations are not very diverse. Minority populations form a very small fraction of the trial populations, much below their proportion in the US population leading to concerns about the effectiveness of approved products in populations under-represented in clinical trials. Since 2014, FDA’s Action Plan to Enhance the Collection and Availability of Subgroup Data requires … Read more
This week FDA announced that it sent Warning Letters to 14 manufacturers of about 65 dietary supplements making claims to treat cancer. One wonders what triggered this event and why did it take this long as obviously these companies did not spring up overnight. FDA’s news release about this event painted a rather innocent picture; … Read more
The regulators publish lists of common deficiencies to create awareness about the kind of concerns raised by auditors in a given period. Such lists are useful to understand the common areas of error and may help reduce those findings in future at other organizations. Few weeks back, MHRA, the regulators in the UK, published common … Read more
Last month, FDA issued a Warning Letter to a California medical foods company, Targeted Medical Pharma (TMP), for conducting clinical trials without an IND. This is an interesting case study that highlights common regulatory issues with most companies doing clinical trials, and more specifically medical food and supplement developers. First, FDA regulates products based on … Read more
FDA does not treat most healthcare related smart-phone apps as medical devices, leaving it to the FTC and state regulators to regulate apps based on claims and complaints. Healthcare apps, mostly hosted on Smartphones, smart watches and other wearable devices, are popular due to high acceptance by consumers and seemingly endless possibilities. Apps can be … Read more
On 21 March 2017, the State of Arizona became the first state to pass the “Free Speech in Medicine Act” which allows manufacturers to practically discuss all kinds of off-label information with doctors and healthcare providers, without fear of prosecution. The day after, a similar bill, “Medical Product Communications Act, 2017”, was introduced in the … Read more
This week European Medicines Agency (EMA) announced suspension of the approval of 331 drugs due to gross data integrity violations at an Indian CRO. This is the third episode of its kind in the last 2 years and exposes a major defect in the regulatory review process in EU. One wonders how the CROs managed … Read more
The FDA’s Office of Regulatory Affairs (ORA), which is responsible for all audits conducted by FDA, is undergoing a major reorganization starting 17th May this year, which is expected to dramatically change how FDA audits. ORA will distribute its auditors into five specialized commodity-based groups, plus one group for clinical trial audits. This is radically … Read more
A recent study by the Tuffs Center for the Study of Drug Development indicates that on an average the 505(b)(2) NDAs take about 5 months longer to get approval from the FDA compared to the new molecular entities (NMEs). However, this is an incomplete story. The authors of the survey specifically looked at the time … Read more
