Commissioner Scott Gottlieb and center for drug evaluation and research (CDER) director Janet Woodcock have insisted that the FDA is maintaining “strong oversight of generic drug quality issues domestically and abroad”.
Allegations of substandard quality controls are not a new phenomenon for the generics industry. However, it is rare for an industry regulator to produce as comprehensive and pointed a response to such criticism as has just been published by the US Food and Drug Administration (FDA).
In a lengthy statement – apparently positioned as a rebuttal to media coverage suggesting deficiencies in the FDA’s quality oversight...
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.
