Latest News & Analysis
In addition to our daily in-depth coverage of key regulatory events relating to the coronavirus pandemic, we’re bringing you selected brief insights into the impact on biopharma commercial activities.
With inspectors no longer out in the field, they have more time to wrap up work on previously completed facility evaluations, attorney Howard Sklamberg says; inspections freeze could delay manufacturers’ abilities to bring facilities into compliance following adverse inspection findings, as well as agency reclassifications of facility status.
The US FDA clarifies that drugs in shortage are not considered “essentially a copy” of an approved drug and can be compounded by traditional pharmacies and outsourcing facilities. This clarification is one of several recently announced by the agency.
Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.
Medical products that do not fully comply with Canadian requirements but are manufactured according to comparable standards are being allowed into the country to deal with COVID-19-related shortages.
A randomized COVID-19 study spanning the whole of the UK could help to bolster the UK’s reputation as a location for future clinical trials. It is also being seen partly as the result of the UK regulator's "decisive action" in fast-tracking trials for potential COVID-19 therapies.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The economic stress on payers caused by the pandemic will cause a setback in the development of payment approaches for regenerative therapy, Blue Cross Blue Shield executive warns.
The Trump administration says a COVID-19 vaccine could be available in as little as 12 months, but most experts think that is overpromising unless safety or efficacy standards are sacrificed. Many are urging pivotal studies that look at clinical outcomes, not surrogates, for US FDA approval.
Intellectual property rights are in the spotlight again, after the World Health Organization and the Medicines Patent Pool announced initiatives to help ensure that all countries will be able to access products being developed for COVID-19.
France has announced a number of emergency measures to protect drug supplies threatened by the spread of the coronavirus.
Coronavirus Notebook: US FDA's Paper Push, Industry Execs/US Officials Emphasize Their Collaboration
Dispatches from a world turned upside down include the US FDA expressing confidence in Chinese manufacturers – to make their GDUFA payments; projections of drug shortages for ventilator patients; and the launch of new hydroxychloroquine studies.
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