A Changing World in Gene Therapy Research: Exciting Opportunities for Medical Advancement and Biosafety Challenges.

Introduction: We previously reported on the United States' regulatory environment evolving to accommodate an emerging boom in gene therapy research. Several important developments have transpired in the 2 years since that article was published, including the coronavirus disease 2019 (COVID-19) pandemic and the drive for large-scale testing of vaccines containing recombinant or synthetic nucleic acid molecules. This report highlights key developments in the field with a focus on biosafety and issues of note to biosafety professionals with responsibilities over clinical research. Discussion: We provide guidance for performing risk assessments on the currently approved gene therapy products as well as the most utilized types of investigational products in clinical trials. Areas of focus include the prominent approaches utilized in the three major areas of research: oncology, infectious diseases, and rare diseases. Conclusion: The COVID-19 pandemic has created several opportunities for continued growth in gene therapy. National vaccination campaigns will result in greater public acceptance of gene therapy research. Technological advancements that made the vaccine race possible will spur the next generation of research. Advancements born in the developed world set the stage for the creation of therapeutics to treat greater numbers in the developing world and have the potential for massive benefits to global public health. Biosafety professionals and Institutional Biosafety Committees play key roles in contributing to the safe evidence-based advancement of gene therapy research. Biosafety professionals responsible for clinical research oversight must be aware of emerging technologies and their associated risks to support the safe and ethical conduct of research.

Analysis of the renewed European Medical Device Regulations in the frame of the non - EU regulatory landscape during the COVID facilitated change.

The term "Medical devices" includes technology-based devices or articles, both basic and complex. Due to these types of variations, a strict, robust, transparent, and sustainable regulatory framework is required. In recent clinical practice, incidents including the breast implant and the hip replacement crisis have made it necessary to improve the regulatory and compliance approaches for the industry to ensure the manufacturing and distribution of safe and innovative MDs within the EU. In response to this, the EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector, address critical safety issues and support innovation. The new regulation (EU) 2017/745 on Medical Devices (MDR) is now applicable from May 26 2021 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 will take effect from May 2022.In this review, we aim to provide an update on the new Medical Device Regulations in the context of the current medical needs of the world, and also to give a glimpse at the non-EU regulatory landscape. Finally, we take a look at the closed-system transfer devices (CSTD) and COVID facilitated changes promoting demand for continuous improvement and trends in the pharmaceutical and medical industry related areas.

The future of abortion is now: Mifepristone by mail and in-clinic abortion access in the United States.

The COVID-19 pandemic disrupted health care delivery in all aspects of medicine, including abortion care. For 6 months, the mifepristone Risk Evaluation and Mitigation Strategy (REMS) was temporarily blocked, allowing for the remote provision of medication abortion. Remote medication abortion may become a dominant model of care in the future, either through the formal health system or through self-sourced, self-managed abortion. Clinics already face pressure from falling abortion rates and excessive regulation and with a transition to remote abortion, may not be able to sustain services. Although remote medication abortion improves access for many, those who need or want in-clinic care such as people later in pregnancy, people for whom abortion at home is not safe or feasible, or people who are not eligible for medication abortion, will need comprehensive support to access safe and appropriate care. To understand how we may adapt to remote abortion without leaving people behind, we can look outside of the U.S. to become familiar with emerging and alternative models of abortion care.