The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and biological products.
Industry and other stakeholders want the US Food and Drug Administration (FDA) to provide more clarity and ensure flexibility in a revised guidance on how drug and medical device makers should communicate with payors and other stakeholders about their products.
The US Food and Drug Administration (FDA) on Thursday released its proposed commitment letter for the Prescription Drug User Fee Act (PDUFA VIII) program, outlining its performance goals and program enhancements for the program for FY 2028-2032.
Following months of negotiations with industry, the US Food and Drug Administration (FDA) has published its proposed commitment letter for the Generic Drug User Fee Amendments (GDUFA IV) program.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has released a revised guide for inspectors and the pharmaceutical industry outlining the general principles of qualification and validation studies in pharmaceutical manufacturing facilities.
Drug, regulatory, and laboratory animal testing groups want the US Food and Drug Administration (FDA) to ensure flexibility in choosing when to rely on animal testing and when other forms of data may be sufficient for cancer drug safety studies.
The International Medical Device Regulators Forum (IMDRF) has finalized a technical document outlining how regulatory agencies may adopt predetermined change control plans (PCCP). The document lists principles for regulators to consider when developing their own PCCP regulations, as well as key elements to include in manufacturers' PCCPs.
The US Food and Drug Administration recently issued warning letters to an over-the-counter (OTC) drugmaker in India for submitting falsified logbooks to the agency. The agency also warned two other OTC firms for multiple violations of good manufacturing practice (GMP), including testing violations.
The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products.
US Food and Drug Administration (FDA) officials said the next iteration of the Medical Device User Fee Amendments (MDUFA VI) will focus on improvements in consistency during the review process and promoting domestic priorities, rather than pursuing shorter review timelines compared to MDUFA V.
