The FDA Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) has launched a new online training course: Best Practices for Communication Between FDA and IND Sponsors During Drug Development.*
The one-hour course describes best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public.
*Note: course begins playing automatically, with audio narration.
- CDER SBIA Learn - courses and resources including new drug development and safety, regulatory submissions, and more
- More from CDER SBIA
- More FDA training and continuing education resources
Data quality course: register by Feb. 24
FDA and the University of Texas Medical Branch, Galveston National Laboratory collaborate to provide an annual training course in how to meet Good Laboratory Practice (GLP) requirements in high and maximum biocontainment security level (BSL-3 and -4) laboratory facilities.
This year's course will be held April 24-28, 2017 at the National Institutes of Health in Bethesda, MD. Continuing education credits may be available for healthcare professionals (physicians, nurses, pharmacists and veterinarians). Register by noon February 24, 2017.
Guidance and information for industry
- From HHS - Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) for Zika virus vaccines - the Acting Secretary is issuing a Declaration pursuant to the Public Health Service Act to provide liability immunity protection for activities related to Zika virus vaccines consistent with the terms of the Declaration - also see PREP Act info from HHS and PREP Act Q&As (February 10, 2017)
- Draft guidance for industry #236 - Regulation of Mosquito-Related Products (PDF, 74 KB) - comment by February 21, 2017 (Federal Register notice) - clarifies which mosquito-related products FDA regulates and which such products EPA regulates - also see: FDA Requests Comments on Documents Related to Certain Biotechnology and Mosquito-related Products and Oxitec Mosquito (January 19, 2017)
- Draft guidance for industry #187 - Regulation of Intentionally Altered Genomic DNA in Animals (PDF, 200 KB) - comment by April 19, 2017 (Federal Register notice) - also see: FDA Requests Comments on Documents Related to Certain Biotechnology and Mosquito-related Products and Q&A on FDA Regulation of Intentionally Altered Genomic DNA in Animals (January 19, 2017)
- New! March 8-9, 2017: Examining Opportunities for the Future of Medical and Public Health Preparedness: A Workshop (Washington, DC), hosted by the National Academies of Sciences, Engineering and Medicine, Health and Medicine Division
- March 9, 2017: Vaccines and Related Biological Products Advisory Committee (Rockville, MD and webcast) - the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season
- April 6, 2017: Public workshop - Emerging Tick-Borne Diseases and Blood Safety(Bethesda, MD) - to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions - register by March 23, 2017
- New! April 25-28, 2017: Preparedness Summit (Atlanta, GA) (fee) - FDA's Gregory Measer, JD, will present Beyond the Last Mile: Monitoring and Assessing Medical Countermeasure Use in Response to Public Health Emergencies
In case you missed it
- From the National Academies of Sciences, Engineering, and Medicine - Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers: Proceedings of a Workshop (February 1, 2017)
- From NIAID - Investigational mRNA Vaccine Protects Mice and Monkeys from Zika Virus Infection - Results show promise for new vaccine platform (February 2, 2017)
- From HHS - The Role of Public-Private Partnerships in National Health Security and From lessons learned to planning tools: Find out how you can help communities cope with disasters (January 27, 2017)
- Texas has identified the first instance of a laboratory-confirmed Zika infection in a pregnant Texas resident who did not travel outside the state (January 25, 2017)