After issuing a draft version of the guidance on the competitive generic therapy pathway meant to incentivize the development of generics for drugs that lack competition in February 2019, the US FDA has now issued the final guidance that includes several clarifications.
The US Food and Drug Administration has issued a finalized guidance on its designation process and criteria for competitive generic therapies. In order to bring clarity to the CGT pathway in the US, the 20-page final guidance “includes several clarifications about the CGT program and its exclusivity provisions.”
After receiving more than 350 CGT requests, the FDA insisted that while the agency may at the request of the...
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.
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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.
