iwewlkws 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
FDA wants to encourage food manufactures to be able to claim the health benefits of their products. Claims about the nutritional properties of food and ability to reduce the risk of health-related conditions can be made. This is a new and significant development. In the past , FDA had objected when food manufacturers claimed that … Read more
This Friday, the 4th of May 2018 is the last day FDA will accept most submissions to CDER and CBER and several to CDRH in paper format. Starting 5th of May 2018, almost all INDs, market approval applications, most DMFs, except Type III DMFs, can only be submitted electronically. Also all amendments, request for meetings, … Read more
Last week Senator Chuck Grassley of Iowa sent a letter to FDA asking about the outcome of a Warning Letter issued last year to a stem cell clinic and in the process raised issues that could affect regulation of all similar clinics by FDA. In August 2017, FDA issued a Warning Letter to US Stem … Read more
Since the inception of the Breakthrough Therapy Designation (BTD) program over 5 years ago, FDA granted this designation to 63 products, and approved 17 products under this program. But it also took back the designation from 14 of them, 5 in last year alone. That’s a whopping 22% of the BTDs; more than 1 out … Read more
This week FDA rescinded a previous decision to refuse-to-file (RTF) an NDA from Alkermes for a depression drug without the company addressing any of the deficiencies and additional data requirements listed by FDA at the time of the RTF. The company released a statement claiming that the reversal of the FDA’s decision came about due … Read more
