Information for industry

Information for industry FDA issued a draft guidance for industry, Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention (PDF, 120 KB), to assist sponsors in all phases of development of antiviral drugs for the treatment or prevention of smallpox (variola virus) infection. This draft guidance addresses nonclinical development, key study design considerations for animal efficacy studies to support potential new drug application (NDA)/biologics license application (BLA) submissions under the Animal Rule, and considerations for obtaining a human safety database. This draft guidance revises the draft guidance for industry entitled Smallpox (Variola) Infection:  Developing Drugs for Treatment or Prevention issued on November 23, 2007. Submit comments  by September 10, 2018. (July 10, 2018) Drugs must meet quality standards that ensure every dose is safe, effective, and capable of providing its intended benefit. Quality metrics help with monitoring quality control systems and processes to ensure these standards are met. FDA's new Quality Metrics Feedback Program, developed in response to stakeholder feedback, encourages meetings with FDA and drug manufacturers to initiate discussions on quality metrics. The agency’s new Quality Metrics Site Visit Program (CDER and CBER) provides on-site, first hand learning opportunities to FDA staff and also provides our stakeholders with more opportunities for quality metrics dialogue with FDA. Submit a proposal to participate in this program by August 28, 2018.  In response to public feedback, FDA updated the format of the Antibacterial Susceptibility Test Interpretive Criteria web pages for clarity. The new format includes the pathogens that FDA recognizes as part of a standard and any exceptions, additions, or additional FDA-identified susceptibility test interpretive criteria for certain drug-bacteria combinations not included in a recognized standard. Also see: FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria (June 27, 2018) FDA announces program to enhance early communications with biological product developers - The FDA’s new INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting program was created to facilitate early interactions between sponsors and CBER staff. It replaces the existing CBER pre- pre-Investigational New Drug (IND) meeting process for all products across the center. (June 22, 2018) New webinar recording available: FDA’s Overview of the Regulatory Framework and FDA's Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US - also see more webinars, presentations, and articles on biosimilars (June 20, 2018) More: MCM-Related Guidance by Date