On February 4, 2020, FDA issued a press release regarding the issuance of an emergency use authorization (EUA) (here) to allow for emergency use of a Coronavirus diagnostic panel by Centers for Disease Control and Prevention (CDC)-qualified labs across the country. Previously, the panel’s use was limited to only CDC laboratories. This additional step […]
Recently, FDA has posted (here) that Metformin, from several sources, tested by FDA showed that the levels of N-nitroso-dimethylamine (NDMA) in the drug are below the levels of detection (here). Great news! NDMA belongs to the nitrosamine family, and is one of the well-known animal carcinogens and a suspected human carcinogen. The nitrosamines, including NDMA, […]
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement on Monday, February 3, 2020 (here) regarding their collaborative plans to advance competition in the biologics market. This joint effort is intended to address misinformation and anti-competitive behavior that may impede competition between biologic drug products. A significant focus […]
“Complete” seems like a simple unambiguous word. So why do so many firms struggle with complying with the following two predicate rules of cGMP compliance? 21 CFR 211.188 Batch production and control records (here) “Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the […]
The World Health Organization (WHO) issued a draft guidance document titled “Guideline on Data Integrity” (October 2019) and within the document there is the statement: “Quality risk management (QRM), control strategies and sound scientific principles are required to mitigate such (Data Integrity) risks” and then further it states: “application of QRM with identification of all […]
The International Society of Pharmaceutical Engineering (ISPE) held their premier Global Pharmaceutical Regulatory Summit conference this past Thursday and Friday (December 5 – 6, 2019) in Bethesda, MD. The theme of this year’s conference was “Igniting Innovation in Development & Quality During Lifecycle Management”. The conference opened with excellent keynote presentation from Janet Woodcock (Director […]
N-Nitrosodimethylamine (NDMA), which was previously found in angiotensin II receptor blockers (the ‘sartans”), which are blood pressure medications, and more recently, in ranitidine (a heartburn medication) has caused nationwide recalls of the products. Now there is a hint that metformin, a widely used drug for diabetes, may be implicated as well, as Singapore’s Health Sciences […]
Training Fundamentals: Important to Baseball and the Analytical Laboratory By Tim Rhines, Ph.D | December 6, 2019 | Compliance, FDA, Laboratories, Science & Technology | 3 | Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training. At this time, team management is evaluating where the team succeeded and where improvement is needed. It […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
In a guidance posted today, the Center for Veterinary Medicine (CVM) discusses its enforcement discretion policy for the use of bulk substances in the compounding of drugs used for non-food-producing animals and, to a more limited extent, for food-producing animals. Unlike the statute and regulations for human drugs, there are no provisions for compounding animal […]
