The Medical Device Innovation Consortium (MDIC) has been hard at work on the Make CAPA Cool program in an effort to beef up device makers’ corrective and preventive action (CAPA) programs. Kathryn Merrill, regulatory program director for Dublin-based Medtronic plc, said on an April 26 webinar that participants in the program have shaved CAPA times from 381 days to as few as 63 days, an improvement that industry hopes will ward off warning letters and product quality issues.
In addition to safety questions about its COVID-19 vaccine, Johnson & Johnson is facing manufacturing challenges as a key partner, Emergent Biosolutions Inc., has yet to get FDA approval to manufacture or distribute the vaccine or its components in the U.S. That approval could be awhile in coming. On April 21, a day after completing its onsite inspection of Emergent’s Bayview plant in Baltimore, Md., the FDA released Form 483 from its inspection, revealing nine observations related to cross-contamination issues, lack of employee training and poorly designed and maintained facilities.
DUBLIN – The Biden administration’s proposals on global corporation tax reform have set alarm bells ringing across the Irish government, as officials digest the possible implications of the plan for Ireland's foreign direct investment model of economic development.
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.
Months of talks between Johnson & Johnson (J&J) and Merck & Co. Inc. about a COVID-19 vaccine manufacturing partnership came to fruition March 2 with the Biden administration hailing the deal as an “unprecedented historic” agreement between two long-time rivals.
Although the global impact of a novel virus like SARS-CoV-2 has so far reached devastating proportions, it has spurred science at an unprecedented rate with potential vaccines developed under a year now nearing U.S. authorization. But while some may say the end to this pandemic is in sight, an actual date is blurry at best, as manufacturing and supply capabilities muddy the outlook.
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
With the economy and public health on the line, U.S. President Donald Trump thumped his Made in America pulpit again Thursday on a campaign swing through Ohio, in which he vowed to bring the pharmaceutical supply chain home over the next four years.
“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.
