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
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
New diagnostics authorities, accelerated approval council featured in Senate user fee bill
Posted 31 May 2022 By Ferdous Al-Faruque
The Senate Health, Energy, Labor and Pensions (HELP) committee has introduced its version of the user fee reauthorization bill. Like its sister bill in the House, the proposed legislation would introduce new guardrails around the US Food...
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
User fee reauthorization bill advances in the House, Senate eyes different riders
Posted 18 May 2022 By Ferdous Al-Faruque
The House Energy and Commerce committee voted unanimously to send legislation to reauthorize the US Food and Drug Administration’s (FDA) user fee programs to the floor in a 55-0 vote. The bill has significantly different riders from one ...
Regulatory NewsRegulatory News
Euro Convergence: AI, notified body shortage top health authorities session
Posted 11 May 2022 By Ferdous Al-Faruque
AMSTERDAM – European healthcare product regulators should begin to focus on harmonizing guidance on artificial intelligence/machine learning (AI/ML) across regulatory regimes, according to a panel of health authority representatives at a...
This Week at FDAThis Week at FDA
This Week at FDA: What we learned at MedCon, looking to RAPS Euro Convergence and more
Posted 06 May 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 we’ve been covering the annual MedCon ...
Regulatory NewsRegulatory News
Two OTC manufacturers warned for inadequate investigations, lax testing and validation practices
Posted 12 April 2022 By Joanne S. Eglovitch
Two domestic drug manufacturers were criticized in warning letters recently sent by the US Food and Drug Administration (FDA) for similar good manufacturing practice (GMP) violations tied to poor failure investigations, and slipshod prog...
     
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Books Books
Lifecycle Management Through the Rx-to-OTC Switch
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Lifecycle Management Through the Rx-to-OTC Switch is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.
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Promotion of FDA-Regulated Medical Products
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This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
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Eclectic Science and Regulatory Compliance: Stories for the Curious
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This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
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Communication and Negotiation
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This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
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Choosing the Right Regulatory Career
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Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.
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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
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A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
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From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories
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This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
     
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