Prahsant Kumar The informed consent for any clinical trial requires the sponsor to inform the potential participants about available treatment options outside the trial. For life-threatening indications, it would mean telling the patients that they could get the same investigational drug via the Right-to-Try law without participating in the trial, thereby eliminating the very reason these patients … Read more
FDA charges fees for most market approval applications but grants waivers to a lot of applicants based on various criteria. A new Guidance document released this week, discusses all the various ways the fees can be reduced or waived by the FDA. In case the applicant has already paid the fee, the fee can be … Read more
In two new Guidance documents released this week, FDA presents a detailed explanation of its requirements for advertisement of approved products. In a slight policy shift, FDA walks away from the rigid enforcement of approved labels and provides some flexibility in marketing communications, while maintaining its control over new uses of approved products. The Guidance … Read more
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
