Prashant Kumar In a stern letter to Tiger Medical of New Jersey, FDA directed the company to stop selling its HIV diagnostic test online. Tiger medical got approval for its Alere Determine™ HIV-1/2 Ag/Ab Combo test kits in 2013 and had been marketing the test online on its website. It was obvious that anyone could purchase the … Read more
FDA leadership believes it can do better at reviewing new drugs by reorganizing its review divisions’ personnel and moving to centralized project management. This week FDA announced details about the planned modernization of the Office of New Drugs (OND) at the Center for Drugs (CDER). Four of the six steps proposed to modernize are incremental … Read more
An opinion piece in the Wall Street Journal this week raises an interesting question: is the era of large Phase 3 clinical trials coming to an end. It is a reasonable argument that when treatments can be customized to patients via personalized therapies, and the benefit of a new drug can be supported by real … Read more
Dietary supplements such as multivitamins are regularly consumed by more than 50% of the population in the US but they may not have much effect on the prolongation of lifespan as shown by a study published this week. A group of nutrition experts conducted a meta-analysis of data from 179 randomized clinical trials conducted over … Read more
Right-To-Try is all set to become the law and the only big change is the shift in the role of FDA from an approver to observer for compassionate use of investigational products. The impact on patient access is limited at best and it does help the drug companies who own such investigational products but eliminating … Read more
One of FDA’s key roles in regulating food is to determine if the ingredients used are GRAS (Generally Recognized As Safe). It also requires food manufacturers to seek approval for using new dietary ingredients (NDI). Although FDA also regulates other aspects of food, such as quality, food manufacturers do not need preapproval from FDA before … Read more
In a joint announcement, FDA and Office of Human Research Protection (OHRP) at NIH released a new guidance document today to address several deficiencies observed in the SOPs and other policy and practices documents maintained by IRBs. In all, FDA and OHRP listed 55 SOPs or written policies covering 5 major areas of compliance that … Read more
A Florida facility was found to manufacture pesticides and human pharmaceuticals using the same equipment leading to contamination of the drugs with pesticides as found by FDA auditors during a GMP inspection. The cardinal rule for GMP is “do no harm”, and the first place you control is contamination with unwanted ingredients. So it is … Read more
In continuation of its efforts to simplify and limit regulation of digital health products, specifically software application that can be used for health-related outcomes, FDA released two new documents this week. Its guidance document on multiple-function devices, namely devices that are used both for regulated and non-regulated functions; FDA describes how it intends to only … Read more
Yesterday FDA took an unprecedented action of filing complaints in Federal courts seeking permanent injunctions to stop two stem cell treatment groups from selling stem cell products, a decision that affects more than 100 clinics in almost 40 states. These two groups were in the news last August when they were raided by FDA inspectors … Read more
