Dr. Reddy’s Laboratories, one of India’s largest pharmaceutical companies, announced Thursday that it has temporarily shut down all of its data center services in response to a cyberattack. Source: Drug…
The Government Accountability Office (GAO) wants the FDA to institute several changes to its three-year-old Office of Laboratory Safety (OLS), which was formed to improve safety in the agency’s labs…
The FDA will not make COVID-19 vaccine developers go through pre-approval inspections for an Emergency Use Authorization (EUA), but companies will have to submit detailed manufacturing data and meet certain…
The FDA released a straight-to-final guidance on steps drugmakers should take to prevent high levels of nitrosamine impurities in their products. Source: Drug GMP Report
Drugs and biologics may fit into one of four categories when it comes to their use in patients age 65 and up, the FDA says in a new draft guidance…
Five drugmakers drew warnings from the FDA for serious quality failures, including “superpotent” products, inadequate stability data and a lack of validation testing. Source: Drug GMP Report
Jack Garvey, founder and CEO of Compliance Architects, a firm specializing in GMP, quality and compliance services, calls for caution in applying the FDA’s new compliant-manufacturing resumption guidance. Source: Drug…
In a proposed rule, the FDA clarifies how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for…
The FDA is urging drugmakers to develop a “resumption plan” to help them prioritize as they get back to normal operations and resume current good manufacturing practice (CGMP) activities that…
Sanofi and GlaxoSmithKline announced in Security Exchange Commission (SEC) filings that the Department of Justice and the U.S. Attorney’s Office for the Eastern District of Pennsylvania have opened an investigation…