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 ...
Regulatory NewsRegulatory News
FDA prevented record number of drug shortages in 2021
Posted 22 June 2022 By Jeff Craven
The US Food and Drug Administration (FDA) prevented 317 drug shortages in 2021, the highest number since the agency began tracking drug shortages in 2012, according to a recent report released by the agency.
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...
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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
FDA considers pilot for lower radiation levels for device sterilization
Posted 08 June 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) may allow medical device manufacturers to modify their radiation sterilization processes to prevent supply shortages. The agency is considering a pilot program to allow lower radiation levels for...
Regulatory NewsRegulatory News
FDA issues Q&A on importation of prescription drugs from Canada
Posted 25 May 2022 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) has offered some clarity on the legal requirements for small entities to import prescription drugs from Canada.
Regulatory NewsRegulatory News
FDA takes steps to relax blood donor requirements
Posted 23 May 2022 By Ferdous Al-Faruque
The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regulatory oversight of blood and blood component donations. The agency says the changes make it easier for donation centers to...
Regulatory NewsRegulatory News
FDA asks manufacturers to develop risk management plans to avert shortages
Posted 20 May 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drug and medical devices are vulnerable to shortages and should be subject to risk management plan (RMP) reporting. The guidance also reco...
     
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Risk Management Principles for Devices and Pharmaceuticals
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Expanded and updated risk management information on healthcare products around the world.
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21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices
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The RAPS Philadelphia Chapter’s webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices.
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The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment
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This course provides a basic understanding of current supplier management practices and their impact on product quality and patient safety.
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Supply Chain Controls [3.0 RAC]
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Regulation of Regenerative Medicines: A Global Perspective
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How to Better Manage Quality and Risk with a Global Change Control Strategy
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Learn about the contributing factors to building change control system that can help manage risk as well as metrics to consider to drive success.
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EU Regulatory Acronyms & Definitions, Sixth Edition
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An EU reference guide with entries in biologics, medicinal products, and medical devices.
     
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