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.
RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Geethapriya K. Setty, global regulatory affairs manager at Hologic.
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.
RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Erik Vollebregt, partner at Axon Lawyers.
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 Indian government is preventing applicants who submit misleading, fake, or fabricated documents from filing further requests with regulatory authorities.
