Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
Some pharmaceutical companies are asking the US Food and Drug Association to give them more time to assess the presence of cancer-causing nitrosamines in new drug products and approved products.
The reasons are varied. For example, Perrigo Company PLC says that internal testing sites have been affected by stay-at-home orders caused by the COVID-19 pandemic, and that actions such as these orders limit ability to conduct tests and risk assessment
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.
Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview.
Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.
