Regulatory NewsRegulatory News
Study: Accelerated approval pathway working as intended in most cases
Posted 10 August 2022 By Jeff Craven
Over the last several decades, the US Food and Drug Administration’s (FDA) accelerated approval program has largely been working as it was designed to, with about half the products using the pathway being converted to traditional approva...
Regulatory NewsRegulatory News
EMA, HMA outline evolution of DARWIN EU real-world database
Posted 02 August 2022 By Ferdous Al-Faruque
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) plan to launch an ambitious new database to collect real-world data (RWD) from a slew of studies that reviewers can reference for their regulatory decision-mak...
Regulatory NewsRegulatory News
FDA official: Patients play an increasing role in rare disease drug development
Posted 01 August 2022 By Mary Ellen Schneider
Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful clinical benefits, according to Kerry Jo Lee, MD, associate director of rare diseases in the US Food and Drug Administration’...
Regulatory NewsRegulatory News
Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicants
Posted 06 July 2022 By Jeff Craven
Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval after submission compared to batch manufacturing products, according to results from a US Food and Drug Admi...
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FDA approval lowers, but doesn’t eliminate disparities in immunotherapy use
Posted 30 June 2022 By Jeff Craven
Racial, ethnic and sociodemographic disparities that are present in clinical trials and compassionate use agreements for cancer immunotherapy during the pre-approval period are reduced, but not eliminated after the US Food and Drug Admin...
Regulatory NewsRegulatory News
RWD in clinical trials: External control arms take the lead
Posted 23 June 2022 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) has now published four draft guidances spelling out how it will consider real-world data (RWD) in regulatory decision-making, from the use of electronic health records and registries to RWD in no...
Regulatory NewsRegulatory News
Expert proposes changes to accelerated approval reforms in user fee bills
Posted 08 June 2022 By Jeff Craven
With the Senate Committee on Health, Education, Labor and Pensions (HELP) recently releasing the Food and Drug Administration Safety and Landmark Advancements (FDASLA) act from committee, some stakeholders are proposing Congress make cha...
Regulatory NewsRegulatory News
FDA adds transition period to electromagnetic compatibility final guidance
Posted 06 June 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has finalized guidance on medical device electromagnetic compatibility that replaces a 2016 document on the same topic. While the agency is giving medical device sponsors 60 days to adopt the gui...
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