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  • As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

  • The FDA continues to advance new policies, modernize programs and advance opportunities for developing more targeted therapies. Using new technology platforms such as cell and gene therapies and small molecule drugs that target the genomic basis of disease, there are more opportunities to intervene in the underlying mechanisms that cause a disease, and potentially arrest and even reverse its progress.

  • A  report published today by the European Medicines Agency (EMA) shows that the overall sales of veterinary antimicrobials across Europe have decreased by more than 20% between 2011 and 2016. This continues the downward trend seen over the last few years and confirms that European Union (EU) guidance and national campaigns promoting prudent use of antibiotics in animals to fight antimicrobial resistance are having a positive effect.

  • In yet another landmark step to strengthen the food safety and nutrition ecosystem in the country, the government formally notified the very first set of Recruitment Regulations of the Food Safety and Standards Authority of India (FSSAI) in the official gazette on 11.10.2018. This follows closely on the heels of another important milestone a few weeks ago, when almost 500 new posts were created to strengthen the functioning of the Authority.

  • The U.S. Food and Drug Administration approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types. ID CORE XT is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results.

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