Regulatory NewsRegulatory News
FDA tells Dutch API producer to clean up its equipment act
Posted 01 July 2022 By Joanne S. Eglovitch
A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the US Food and Drug Admin...
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 ...
RoundupsRoundups
Asia-Pacific Roundup: India proposes QR codes on key medicines within the year
Posted 21 June 2022 By Nick Paul Taylor
Proposals to include a barcode on drug packaging date back to 2015 when the Indian government released a draft proposal for consultation. The proposal was never finalized because many “pharmaceutical companies showed their inability to i...
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
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
Califf uses budget hearing to advocate for resources, authority to monitor supply chains
Posted 19 May 2022 By Ferdous Al-Faruque
A House appropriations subcommittee hearing on the proposed budget for the US Food and Drug Administration placed the agency’s commissioner, Robert M. Califf, on the hot seat, taking criticism for failing to prevent an infant formula sho...
Regulatory NewsRegulatory News
New report urges more clinical trial diversity, recommends incentives
Posted 18 May 2022 By Ferdous Al-Faruque
A new report commissioned by Congress makes significant recommendations for improving clinical trial diversity, including offering financial incentives that have typically been off the table for ethical reasons. The 403-page report addre...
     
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