Regulatory Focus

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.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, FDA leaders spelled out the case for an upcoming overhaul of the agency’s inspectional operations, the agency’s top biologics regulator proposed steps to make the US more attractive for early stage research, and the agency approved a controversial cancer drug after twice rejecting it.