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
Our pets share not just our homes and hearts but also our life style and diseases. In many ways our dogs and cats are much closer representatives of humans than any test animal. So, can drugs be tested in a clinical trial in our pets to find out the ones that hold more promise in … Read more
This week FDA announced the final rule for determining the “Generally Recognized as Safe” (GRAS) status of food ingredients. The new process replaces the current process of petitioning FDA to affirm the GRAS status, with a voluntary notification about a conclusion that a substance is GRAS under the conditions of its intended use in human food or … Read more
It is critical that a product be properly classified as a drug or medical device. For products where a clear unambiguous scientifically justifiable classification as a drug or medical device cannot be made, the developer are required to make a Request for Designation (RFD) with the Office of Combination Products (OCP) at the FDA. Classification of a given product … Read more
