Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.
A senior US Food and Drug Administration official urged manufacturers to look for tell-tale “anomalies” in data from their contract research organizations given the serious downstream repercussions that could follow a data integrity problem.
“Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” is already the subject of a draft guidance, but FDA officials are directly urging industry to take the issue seriously.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
Also, Latest News From Europe, Canada, Saudi Arabia, Finland, China, And The US
Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
Emerging CRISPR innovations, shifting regulatory landscapes, and rising partnerships are accelerating a paradigm shift in biotech pipelines
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
