iwewlkws This week the Chinese FDA announced results of its year-long investigation into clinical trials conducted in China, and the results were appalling. But its impact on Chinese manufactured drugs sold in the US is likely minimal, at least in the near future. Chinese auditors found that more than 80% of clinical trials contained fabricated and fraudulent data, … Read more
News in the past week has been rife with another drug company gouging the price of a critical life-saving drug with no apparent reason. In a span of 6 years, Mylan raised the price of its EpiPen by 400%, and once again we had all those debates of how pharma companies profit from artificial monopolies and … Read more
Last week, NIH released the final rule for registering clinical trials and reporting results for completed studies. The most important part of the final rule is regarding the submission of results from completed clinical trials. Starting 18 Jan 2017, all completed clinical trials will be required to submit results on clinicaltrials.gov within 1-3 years of study completion … Read more
The first stage of the implementation of the Food Safety Modernization Act (FSMA) officially came into effect this Monday (19 Sep 2016) whereby all large food manufacturers, with 500 or more employees, have to be in compliance with strict food quality and contamination prevention standards. The food GMP regulations require manufacturers to control all aspects of growth, … Read more
FDA has decided that e-cigarettes should be treated the same way as conventional cigarettes but in the medical community there are strong opinions regarding whether these products should be promoted for smoking cessation or discouraged for their potential to promote smoking. It has long been argued that electronic cigarettes are less harmful due to lack of tar, … Read more
For the calendar year 2016, CDER at FDA plans to release more than 100 new guidance documents in 15 areas of interest. The list of guidance documents is a good indicator of FDA-industry interactions and current areas of interest and this year’s list is no different. Several of these will be eagerly awaited by the industry. There … Read more
The United States and New Zealand are the only two countries in the World that allow direct-to-consumer (DTC) advertisement. Each year the US pharma industry spends almost $5 billion on such ads. However, the American Medical Association that represents the doctors believe DTC ads push patients towards costly new drugs with limited experience compared to established treatment … Read more
Bernie Sanders famously said that “people are sick of hearing about Hillary Clinton’s “damn emails”, and perhaps he was right. However, the findings from the FBI investigation of the matter continue to highlight several issues with email security common with many senior executives. Part 11 regulations provide some of the best policies for system integrity and data storage that … Read more
A common question asked when choosing a suitable contract research organization (CRO) is if one should go with a big CRO or a small CRO. There are 751 CROs in the World with about half of them or 332 in the US. Of these, the top 10 CROs account for about 57% of the total revenue in the … Read more
This week FDA announced a major modernization of the GLP rules primarily aimed at adding detailed quality system requirements such as requiring that GLP facilities maintain detailed SOPs on the responsibilities of management, period assessment of the quality system, and electronic documentation. Per the new rules the management of a given facility will be held responsible for … Read more
