FDA CDER Office of Pharmaceutical Quality is offering a five-hour webinar to discuss reporting requirements and expectations for Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR). The statutory reporting requirements are found in 21 CFR 314.81 (for FAR) and 21 CFR 600.14 (for BPDR). FDA will share how it assesses these reports and
A BARDA-Sponsored Phase 2 ARDS Platform Clinical Trial BARDA will host 'Just Breathe – An ARDS Therapeutics Pitch Event' on July 24-28, 2023 to support development of threat-agnostic and host-directed therapeutic candidates to address acute respiratory distress syndrome (ARDS). The event will be held in a virtual format. The Biomedical Advanced Research and Development Authority
A closed meeting of the National Institute of Allergy and Infectious Diseases (NIAID) Special Emphasis Panel will be held August 24-25, 2023 to review and evaluate contract proposals for the NIAID 2023 DMID Omnibus BAA (HHS–NIH–NIAID–BAA2023–1), Research Area 004—Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases (N01). The meeting
The National Biodefense Science Board (NBSB) will convene for a virtual meeting on 28 August 2023. The NBSB provides expert advice and guidance to the U.S. Department of Health and Human Services and the Assistant Secretary of Preparedness and Response regarding current and future chemical, biological, radiological, and nuclear threats, as well as other matters
A closed meeting of the National Institute of Allergy and Infectious Diseases (NIAID) Special Emphasis Panel will be held September 1, 2023 to review and evaluate contract proposals for the NIAID 2023 DMID Omnibus BAA (HHS–NIH–NIAID–BAA2023–1), Research Area 001—Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases. The meeting will be closed to the
The Oak Ridge Institute for Science and Education (ORISE) will host a Genomics and Precision Public Health Issues Enrichment Event from 7-8 Sep 2023 in Atlanta, Georgia. In the past decade, genomics, and precision health approaches such as big data science and machine learning have emerged as important tools for public health. Those entering the
2023 Scientific Computing Days Sharing and Collaboration in the Data Multiverse:Scientific Computing for Public Health Solutions The 11th annual Scientific Computing Days symposium is a conference promoting the latest advances in scientific computing technologies. The event’s goal is to help FDA improve the application of technology and scientific computing in support of the FDA’s public
The CDC will host the OneLab Summit 2023 from 3-5 October 2023 online. This free, three-day virtual summit connects laboratory professionals in real time to support a unified response to laboratory training needs. Attendance is open to anyone interested or involved in the laboratory profession. OneLab Summit programming is most relevant to people who provide
The annual BARDA Industry Day (BID) conference will be held 13-14 November 2023 in Washington DC and via virtual participation. BID2023: Driving Innovation for Preparedness & Response will feature presentations from BARDA leadership, U.S. government partners, and industry on medical countermeasure (MCM) priorities and public health innovation. Attendees will also have an informal opportunity to
