A set of three guidance documents the FDA released Sept. 25 provides a look into the agency’s implementation of its new Accreditation Scheme for Conformity Assessment (ASCA) pilot program for…
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may fit into one of four categories when it comes to their use in patients age 65 and up, the FDA says in a new draft guidance…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…