As infections and deaths continue to surge in some countries so does the demand for unfettered access to the technologies behind COVID-19 vaccines and other medical products. In seeking that access, several countries are stressing the need to develop their own manufacturing capacity as they look beyond the current pandemic.

Roughly a year and a half after the start of the COVID-19 pandemic, many unknowns remain about the future of the virus. How it will mutate, how long protection from either illness or vaccination will last, when it will cease to be a pandemic and instead be endemic, even whether the worst is still ahead. And there is also an increasing acknowledgment that there remain unknowns about SARS-CoV-2’s past.

The COVID-19 pandemic’s direct and indirect toll on the human condition is beyond calculation, but the effect on FDA regulatory activity is easier to assess. The problem for device makers is that a number of draft and final guidances are stuck in a pandemic-driven regulatory limbo, which seemingly guarantees that some compliance and product development efforts will run afoul of the agency’s expectations and potentially delay a product’s market access.

The Made in America Tax Plan President Joe Biden is proposing to pay for his $2 trillion U.S. American Jobs Plan could change the way multinational drug and device companies do business, as well as curb M&As that take advantage of global tax benefits.

DUBLIN – Last May, a quartet of Dutch biotech industry veterans gathered for a socially distanced outdoor meeting in a private garden in Leiden to discuss what could be done to prevent the present COVID-19 fiasco from ever occurring on such a scale again. A new startup, Leyden Laboratories BV, emerged from that conversation, and it has just raised €40 million (US$47.3 million) in a series A round to develop broad-spectrum, self-administered, intranasal antiviral drugs to prevent infection.

CAJICA, Colombia – The COVID-19 pandemic has exposed the weaknesses of Mexico’s techno-vigilance system, along with a chronic lack of reporting of inventories and adverse effects related to medical devices in use. These weaknesses were exposed during previous pandemics but the country’s antiquated tracking and reporting system has not changed.

The first Senate hearing for the nomination of Xavier Becerra as Secretary of Health and Human Services included the predictable questions about his qualifications, given his position as attorney general for the state of California. However, the candidate repeatedly emphasized price transparency for both hospitals and drug manufacturers, the latter of which are still laboring under the perception that price gouging is a common practice.

The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion.

U.S. FDA warning letters have been a staple of regulatory life since the late 1990s, but James Boiani, a regulatory attorney with Epstein, Becker & Green P.C., said it’s no stretch of the imagination that warning letter volumes will jump in 2021. This is to some extent because the volume of warning letters dropped significantly over the past four years, and Boiani advised that all FDA-regulated industries will see more warning letters unless they are communicative with the agency about inspectional findings.