Regulatory NewsRegulatory News
PFDD: Draft guidance seeks to demystify clinical outcomes assessments
Posted 30 June 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) this week issued a sweeping draft guidance intended to help stakeholders incorporate patient experience data through the use of meaningful clinical outcome assessments (COAs).
Regulatory NewsRegulatory News
House committee sends FDA budget to floor vote
Posted 23 June 2022 By Ferdous Al-Faruque
The US House Appropriations Committee has sent the Food and Drug Administration’s FY2023 funding bill to the full House for a vote. It includes an amendment to stop Russian drugmakers from selling their products in the US to protest the ...
This Week at FDAThis Week at FDA
This Week at FDA: FDA authorizes COVID vaccines for youngest children; Congress holds budget, pandemic hearings
Posted 17 June 2022 By Ferdous Al-Faruque
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. It was budget week on the Hill and with that, we...
Regulatory NewsRegulatory News
Senate HELP committee tussles over additional COVID funding
Posted 16 June 2022 By Ferdous Al-Faruque
Partisan disagreement set the tone at a 16 June hearing of the Senate Health, Education, Labor and Pensions (HELP) Committee, where Democrats on the committee warned lack of additional COVID-19 funding would set back the progress made in...
Regulatory NewsRegulatory News
House subcommittee moves FDA $3.6B budget forward
Posted 15 June 2022 By Ferdous Al-Faruque
Lawmakers in the House Appropriations agriculture subcommittee have sent their FY 2023 budget package that includes funding for the US Food and Drug Administration (FDA) to the full committee, proposing $3.6 billion in discretionary fund...
Regulatory NewsRegulatory News
Senate HELP sends user fee reauthorization bill to floor vote
Posted 14 June 2022 By Ferdous Al-Faruque
The US Senate Health, Energy, Labor and Pensions (HELP) committee advanced a bill that would reauthorize the Food and Drug Administration (FDA) to collect medical product user fees. It differs significantly from a sister bill recently pa...
Regulatory NewsRegulatory News
All eyes on Senate after House passes user fee reauthorization bill
Posted 09 June 2022 By Ferdous Al-Faruque
The US House overwhelmingly passed its Food and Drug Administration (FDA) user fee reauthorization bill that has been delayed largely due to the COVID-19 pandemic. Now the ball is with the US Senate, which is expected to hold a postponed...
Regulatory NewsRegulatory News
EU regulators offer new guidance on complex clinical trials
Posted 03 June 2022 By Ferdous Al-Faruque
European regulators published a question and answer document that they hope will give more clarity on how complex clinical trials (CCT) should be conducted. The document aims to answer some basic questions, such as what to consider in ...
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