A global World Health Organization (WHO) survey, published Aug. 31, provides a broader picture of the impact COVID-19 has had on health systems worldwide. Data collected from 105 countries in five regions from March to June 2020 showed that 90% of the countries experienced disruption to health services, with low- and middle-income countries reporting the greatest difficulties. Most countries reported the suspension of many routine and elective services, while critical care such as cancer screening and treatment and HIV therapy saw “high-risk interruptions” in low-income countries, according to the WHO survey. For example, 70% of the countries reported frequent disruptions in routine immunization and outreach services, 69% reported disruptions in the diagnosis and treatment of noncommunicable diseases (other than cancer), 61% noted disruptions in facility-based services and in mental health treatment, and 55% reported disruptions in cancer diagnosis and treatment. In addition, 46% of the countries responding to the survey had disruptions in malaria diagnosis and treatment, 42% in tuberculosis detection and treatment, and 32% in antiretroviral treatment. About a fifth of the responding countries also noted a disruption in emergency services. Such disruptions are “expected to have harmful effects on population health in the short-, medium- and long-term,” WHO said. It added that the survey “highlights the need to improve real-time monitoring of changes in service delivery and utilization as the outbreak is likely to wax and wane over the next months.” To help countries better respond as the pandemic continues, WHO is developing the COVID-19: Health services learning hub, a web-based platform that will allow sharing of experiences and learning from innovative practices.
The FDA published a new batch of 36 product-specific guidances to help streamline the development of generic drugs. The batch includes 19 new draft guidances and 17 revised ones, with 27 addressing products that have no approved generic and nine referencing complex products. The guidances cover treatments for diseases such as HIV, prostate cancer and Helicobacter pylori infection. In addition, the FDA updated its upcoming product-specific guidances for complex generic drug product development web page, which provides a look at the agency’s plans for issuing new or revised product-specific guidances in the coming year for complex products. Comments should be submitted to Docket No. FDA–2007–D–0369 by Oct. 30, according to a notice published in the Aug. 31 Federal Register.
Recognizing the challenges some small businesses are facing in raising capital during the pandemic, the The U.S. SEC is extending its temporary final rules under Regulation Crowdfunding through Sept. 1, 2021, to expedite the offering process for smaller, previously established companies directly or indirectly affected by COVID-19. The temporary rules provide flexibility for eligible issuers to gauge interest in a Regulation Crowdfunding offering before preparing full offering materials and then, once launched, to close the offering and have access to funds sooner than would be possible otherwise. Additionally, the rules provide an exemption from certain financial statement review requirements for issuers offering up to $250,000 of securities in reliance on Regulation Crowdfunding within a 12-month period, according to a notice scheduled for publication in the Sept. 2 Federal Register. The rules will apply to offerings under Regulation Crowdfunding between May 4, 2020, and Feb. 28, 2021.
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) awarded 11 grants with a total first-year value of about $17 million to establish the Centers for Research in Emerging Infectious Diseases. “The global network will involve multidisciplinary investigations into how and where viruses and other pathogens emerge from wildlife and spill over to cause disease in people,” according to the NIAID. The institute said it intends to provide about $82 million over five years to support the network. Each center in the network will include collaborations with peer institutions in the U.S. and 28 other countries and will focus on specific regions in the world. RTI International, of Research Triangle Park, N.C., in collaboration with Durham, N.C.-based Duke University, will establish a coordinating center to support network-wide activities such as data management, outbreak research response and quality control for biospecimens, assays and reagents. It also will administer a pilot research program for early career investigators.