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
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
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
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
FDA official breaks down novel excipient pilot program
Posted 11 October 2021 By Kari Oakes
Although a new excipient might offer advantages such as better drug bioavailability, enhanced absorption, or the potential for a more abuse-deterrent formulation for opioids, for example, the development process can be slowed when FDA do...
Regulatory NewsRegulatory News
FDA studies consumer perception of DTC drug ads, willingness to report false claims
Posted 20 August 2021 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on how to measure consumer perceptions of the information presented in ads.
Regulatory NewsRegulatory News
FDA reaffirms that CBD products can’t be marketed as dietary supplements
Posted 13 August 2021 By Jeff Craven
The US Food and Drug Administration (FDA) has objected to New Dietary Ingredient (NDI) notifications submitted by two developers of full-spectrum hemp extract products, telling the companies an earlier decision by the agency to consider ...
     
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Argumentation and Persuasion for Regulatory Professionals
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to utilize structures to think through argumentation.
Books Books
Eclectic Science and Regulatory Compliance: Stories for the Curious
Member: $15.00 Nonmember: $20.00
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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Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Globalization of Clinical Research Trials and Investigations [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course will cover regulatory requirements for conducting pivotal clinical trials in three countries that are often discussed as critical for global registration—China, India and Japan.
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Communication and Negotiation
Member: $15.00 Nonmember: $20.00
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
Member: $20.00 Nonmember: $25.00
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.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Effective Regulatory Communication [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
In this course, you will obtain an understanding of the complexities and principles of regulatory communication.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Project Management for Regulatory Professionals [4.0 RAC]
4.0 RAC Credits
Member: $465 Nonmember: $640
This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports.
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China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Our experts will explain related guidelines, emergency approval procedures, urgent importations, how they work in practice, what is required during the COVID-19 crisis, and what to expect moving forward.
     
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On-demand On-demand

Argumentation and Persuasion for Regulatory Professionals

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to utilize structures to think through argumentation.
Books Books

Eclectic Science and Regulatory Compliance: Stories for the Curious

Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Globalization of Clinical Research Trials and Investigations [3.0 RAC]

3.0RAC Credits
Member: $365.00 Nonmember: $500.00
This course will cover regulatory requirements for conducting pivotal clinical trials in three countries that are often discussed as critical for global registration—China, India and Japan.
Books Books

Communication and Negotiation

Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.