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CDER’s Office of Pharmaceutical Quality (OPQ) Director Mike Kopcha leads an office of more than 1,300 staff involved in assessing drug marketing applications. FDAnews asked him about OPQ’s challenges, priorities and goals. Read More
A new document from the Medical Device Single-Audit Program (MDSAP) outlines the program’s plan for implementing its Quality Management System (QMS) guidance on how to design, strengthen and develop quality management processes, products, outcomes and services. Read More
Federal funding of clinical studies often goes unreported — or is reported inaccurately — when drug manufacturers apply for patents, says a new report from the Government Accountability Office (GAO) that points the finger at the National Institutes of Health’s (NIH) failure to enforce reporting requirements. Read More
Changes in the user fee program as a result of the Prescription Drug User Fee Amendments of 2022 (PDUFA VII) are detailed in a new FDA final guidance issued on Friday. Read More
The European Medicines Agency (EMA) is seeking public comment on its transparency rules and protection of personal and commercially confidential data submitted to its clinical trials database. Read More
In a Senate hearing on reauthorization of the 2006 Pandemic and All-Hazards Preparedness Act (PAHPA), FDA Commissioner Robert Califf reiterated the agency’s call for better data and more supply chain notification authority to prevent future drug and medical device shortages. Read More
To reflect the more current organizational structure and processes in its Office of Generic Drugs (OGD), the FDA has published a manual of policies and procedures (MAPPs) update focused on bioequivalence (BE) studies with clinical endpoints. Read More
The number of priority review generics applications awaiting FDA action dropped by 25 percent in the first half of fiscal year 2023, signaling that the agency has improved review efficiency, according to a report published Tuesday. Read More
The FDA has adopted the International Council for Harmonization’s (ICH) revised guideline for quality risk management, releasing it in the form of a final agency guidance that advises pharma companies on risk management methodology, risk-based decision-making and managing subjectivity. Read More
Vanda Pharmaceuticals is suing the FDA, charging that the agency illegally revealed proprietary manufacturing information to companies seeking approval for generic forms of two of Vanda’s patented drugs. Read More