Application of DNA sequences in anti-counterfeiting: Current progress and challenges.

Counterfeiting has never been more challenging than during the COVID-19 pandemic as counterfeit test kits and therapeutics have been discovered in the market. Current anti-counterfeiting labels have weaknesses: they can either be duplicated easily, are expensive or ill-suited for the existing complex supply chains. While RFID tags provide for an excellent alternative to current anti-counterfeiting methods, they can prove to be expensive and other routes involving nanomaterials can be difficult to encrypt. A DNA based anticounterfeiting system has significant advantages such as relative ease of synthesis and vast data storage abilities, along with great potential in encryption. Although DNA is equipped with such beneficial properties, major challenges that limit its real-world anti-counterfeiting applications include protection in harsh environments, rapid inexpensive sequence determination, and its attachment to products. This review elaborates the current progress of DNA based anti-counterfeiting systems and identifies technological gaps that need to be filled for its practical application. Progress made on addressing the primary challenges associated with the use of DNA, and potential solutions are discussed.

Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19.

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials is becoming more available, regulators are still reluctant to provide detailed information about how that information is interpreted. As medicines and vaccines come up for approval for treatment of COVID-19, transparency in how pivotal trials are interpreted will be critical in determining how these treatments should be used.