Archive for October 2020
FDA Details ASCA Pilot Program for Devices in New Guidance
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 devices. Source: The GMP Letter
Read MoreFDA Offers Advice on Control of Nitrosamines in Drugs
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
Read MoreFDA Outlines Prescription Drug Labeling for Geriatric Patients
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may fit into one of four categories when it comes to their use in patients age 65 and up, the FDA says in a new draft guidance on geriatric information for prescription product labeling. Source: Drug GMP Report
Read MoreWarning Letter Roundup: FDA Raps Five Firms for Testing, Other Violations
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
Read MoreBe Careful With FDA’s New Compliant-Manufacturing Resumption Guidance
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 GMP Report
Read MoreFDA Provides Clarifications on Evaluations for Intended Use
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 a new use. Source: Drug GMP Report
Read MoreFDA Issues Temporary Guidance on Resuming Normal Drug Manufacturing
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 were modified or delayed due to COVID-19. Source: Drug GMP Report
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