FDA In Brief > FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development

FDA In Brief > FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development





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• FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development - FDA awarded three grants, using its authority under the 21st Century Cures Act, to institutions of higher education and non-profit organizations to study and recommend improvements for the continuous manufacturing of drugs and biological products, as well as similar innovative monitoring and control techniques.Also see: FDA's Emerging Technology Program (August 1, 2018)
• FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs - FDA approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition. (August 8, 2018)
• FDA has launched a new Medication Guide database to replace the current Medication Guide web page. Medication guides are provided with many prescription medicines. A Medication Guide is a form of patient labeling that is part of the FDA-approved prescription drug labeling. Medication Guides address issues that are specific to particular prescription drugs or biologic products and can help patients avoid serious adverse events. (August 8, 2018)
• Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings - Combating antimicrobial resistance continues to be a top priority for FDA. To further these efforts, FDA will soon implement a new, five-year blueprint for how the FDA plans to build on its current programs to advance antimicrobial stewardship in veterinary settings. (July 31, 2018)
• FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Send a letter or email stating interest by August 29, 2018. 
• From HHS - HHS, DoD, Spero co-sponsor novel oral antibiotic development to treat deadly infections - First-of-its-kind public-private partnership takes aim at biothreats, drug-resistant bacteria. (July 16, 2018)
• From the National Institute of Standards and Technology (NIST) - New Cell Lines Produce NIST Monoclonal Antibody for Improved Manufacturing of Biologic Drugs - “Researchers will be able to look at the broad issues currently facing manufacturers of mAb therapeutics with a system that is not proprietary; the NIST cell lines will encourage innovation and exploration that isn’t related to specific product development." (July 31, 2018)
• You want to make a difference. FDA wants to hire you. Follow @FDAJobs on Twitter, or visitwww.fda.gov/jobs.