Energy Department Releases Request for Information on Multi-Sector Uses of Hydrogen
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- Written by Green Liver
- Category: News
Chicago, Illinois - At today’s H2@ Scale project kickoff meeting in Chicago, EERE’s Deputy Assistant Secretary for Transportation Steven Chalk announced the release of a request for information (RFI) soliciting stakeholder feedback on opportunities to enable high volume production and multi-sector use of hydrogen.
Careful oversight of the REMS associated with transmucosal immediate-release fentanyl products
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- Written by FDA Commissioner Scott Gottlieb, M.D.
- Category: News
Washington, DC - On August 3, the U.S. Food and Drug Administration will be hosting a public advisory committee meeting to review data from the most recent assessment of the Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) for transmucosal immediate-release fentanyl (TIRF) products. The FDA will be asking the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the findings from the assessments conducted by manufacturers of these products, as well as additional data about their use patterns and adverse events. Asking the FDA’s advisory committees to take a closer look at this opioid-related REMS reflects our commitment to further evaluating this critical program and making sure we’re providing transparency around its effectiveness and whether any modifications may be necessary.
Is your work-life balance out of balance?
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- Written by Mayo Clinic Staff
- Category: News
Rochester, Minnesota - There was a time when the boundaries between work and home were fairly clear. Today, however, work is likely to invade your personal life — and maintaining work-life balance is no simple task.
Monoclonal Antibody for Improved Manufacturing of Biologic Drugs
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- Written by Michael E. Newman
- Category: News
Washington, DC - When the National Institute of Standards and Technology(NIST) issued the world’s first standardized monoclonal antibody (mAb) in July 2016, the exhaustively analyzed protein known as NISTmAb(NIST Reference Material 8671) was intended as a valuable tool for biopharmaceutical companies. Its purpose: to help ensure the quality of measurement techniques used in the development and manufacture of biologic drug therapies for a wide range of health conditions, including cancers, autoimmune disorders and infectious diseases. Although the molecule has been precisely characterized, the current proprietary method for its production has not.
Governor Brown Announces Appointments
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- Written by IVN
- Category: News
Sacramento, California - Governor Edmund G. Brown Jr. today announced the following appointments:
New efforts to advance antimicrobial stewardship in veterinary settings
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- Written by FDA Commissioner Scott Gottlieb, M.D.
- Category: News
Washington, DC - Antimicrobial resistance is a global public health challenge. Antimicrobial drugs have been widely used in human and veterinary medicine for more than 60 years. When used judiciously, antimicrobials can effectively fight bacterial infections. However, we know that overuse or misuse of these drugs promotes the development of antimicrobial-resistant bacteria.
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