Regulatory NewsRegulatory News
FDA Official: EU privacy regulations impede BIMO inspections, application reviews
Posted 10 August 2022 By Ferdous Al-Faruque
According to a US Food and Drug Administration (FDA) lawyer, the European Union’s privacy regulations are a headache for researchers and regulators trying to share data. Heather Messick, the former lead policy analyst on the EU’s General...
Regulatory NewsRegulatory News
Legal Expert: Too early to tell if SCOTUS ruling will chill FDA regulation
Posted 09 August 2022 By Ferdous Al-Faruque
When the majority of the US Supreme Court (SCOTUS) in late June said that an Obama-era Environmental Protection Agency (EPA) policy to curb climate change was a regulatory overreach, legal experts wondered if it would have a chilling eff...
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: EtO, user fee woes, and product specific guidances
Posted 05 August 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. This week the Environmental Protection Agency (EP...
Regulatory NewsRegulatory News
Califf seeking Congressional assurance user fees won’t run out
Posted 01 August 2022 By Ferdous Al-Faruque
With only two months to go before user fee legislation runs out and no indication Congress will reauthorize it in time, FDA Commissioner Robert Califf sought to assure agency staff that he is doing his best to get ascertain from lawmaker...
Regulatory NewsRegulatory News
This Week at FDA: New guidance on disposable manufacturing materials, Generic Drug Cluster report
Posted 29 July 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. This week, the US Food and Drug Administration (F...
Regulatory NewsRegulatory News
Concerns rise that Congress may miss budget, user fee renewal deadlines
Posted 21 July 2022 By Ferdous Al-Faruque
With just over two months to go, it’s increasingly looking like Congress is going to miss its deadlines to pass a final US Food and Drug Administration appropriations bill and a user fee reauthorization bill.
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PFDD: Draft guidance seeks to demystify clinical outcomes assessments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 ...
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Sponsored Webcast: Advantages of Engaging Ahead: How Partnership & Collaboration Enable eCTD Submission Publishing Success
Wednesday, 24 August 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | NonMember: $0
Certara will demonstrate how how regulatory operations specialist were able to partner with Advaxis, Inc. to optimize regulatory operations processes.
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Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions
Wednesday, 05 October 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | NonMember: $0
This session will cover a comprehensive analysis of the Accelerated Approval program as well as a deep dive into a selection of past examples and precedents.
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Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Combination Products [3.0 RAC]
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This course provides a historical perspective on combination product regulation in the US, and examines the current regulations and policies covering the identification, jurisdiction and review of combination product
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Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $20
This session will cover a comprehensive analysis of the Accelerated Approval program as well as a deep dive into a selection of past examples and precedents.
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Regulation of Regenerative Medicines: A Global Perspective
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Regulation of Regenerative Medicines: A Global Perspective takes a look inside the rapidly evolving cell therapy, gene therapy, and tissue engineering landscape in the US and other key world markets.
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International Combination Products
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This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
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Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development (On-Demand)
1.0 RAC Credits
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During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
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How to Better Manage Quality and Risk with a Global Change Control Strategy
1.5 RAC Credits
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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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Key Regulatory Topics: eCTD
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eCTD guidance documents from the ICH, EMA, and FDA.
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Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD
Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
     
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Audits and Inspections: How to Drive a Standardization Strategy that Sticks (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $25
Audits and inspections: how to drive a standardization strategy that sticks
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Sponsored Webcast: Advantages of Engaging Ahead: How Partnership & Collaboration Enable eCTD Submission Publishing Success

Wednesday, 24 August 2022 (11:00 - 12:00PM)
1.0RAC Credits
Member: $0 | NonMember: $0
Certara will demonstrate how how regulatory operations specialist were able to partner with Advaxis, Inc. to optimize regulatory operations processes.