Regulatory NewsRegulatory News
EMA consults on ICH M12 guideline for drug-drug interaction studies
Posted 25 July 2022 By Jeff Craven
The International Council for Harmonisation (ICH) has released a draft guideline with recommendations on designing, conducting and interpreting drug-drug interaction (DDI) studies involving interactions mediated by enzymes and/or transpo...
Regulatory NewsRegulatory News
CAR T cell product development guidance: Comments ask for CMC details
Posted 29 June 2022 By Mary Ellen Schneider
Both industry and clinicians asked the US Food and Drug Administration (FDA) for clarification related to the evaluation of cellular starting materials in its draft guidance on chimeric antigen receptor (CAR) T cell product development.
Regulatory NewsRegulatory News
FDA adds transition period to electromagnetic compatibility final guidance
Posted 06 June 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has finalized guidance on medical device electromagnetic compatibility that replaces a 2016 document on the same topic. While the agency is giving medical device sponsors 60 days to adopt the gui...
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...
Regulatory NewsRegulatory News
FDA sheds light on conducting human radiolabeled mass balance studies
Posted 10 May 2022 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) has issued draft guidance outlining the clinical pharmacology considerations for human radiolabeled mass balance studies for investigational drugs, including when to conduct the study, the study ...
Regulatory NewsRegulatory News
FDA officials: Firms with strong quality cultures more resilient to data integrity problems
Posted 26 April 2022 By Joanne S. Eglovitch
US Food and Drug Administration (FDA) officials asserted at a 26 April Generic Drug Forum (GDF) that firms with weak quality cultures are more susceptible to submit abbreviated new drug applications (ANDA) with data integrity problems th...
Regulatory NewsRegulatory News
FDA finalizes guidance for drugs and biologics containing nanomaterials
Posted 25 April 2022 By Jeff Craven
The US Food and Drug Administration (FDA) has released its final guidance for industry on human drug and biological products that contain nanomaterials.
     
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Chapter Events Chapter Events
San Francisco Chapter Webcast: Cannabis: Where Are We Now?
Tuesday, 04 October 2022 (10:00 - 11:30AM) 1.5 RAC Credits Member: $0 |Nonmember: $25
This webcast will describe the terminology, and differences between FDA-approved and non-FDA approved cannabis, as well as an overview of current regulations of cannabis based products
On-demand On-demand
Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success.
On-demand On-demand
Understanding Key Components of a Clinical Evaluation
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This broadcast will explain the key changes of clinical evaluation, review phases for clinical evaluation, explain expectations for systematic literature review, and identify types of clinical support data.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Laboratory Practice (GLP) [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides an overview of GLP regulations as they are applied and interpreted by the FDA, EPA and the Organization for Economic Cooperation and Development.
Books Books
Regulation of Regenerative Medicines: A Global Perspective
Member: $145.00 Nonmember: $200.00
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.
On-demand On-demand
Artificial Intelligence: A Regulatory Perspective (On Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will provide an overview of terminology and concepts in Artificial Intelligence, review the regulatory requirements in the EU market, cover real-world examples of commercial solutions
On-demand On-demand
The Aftermath of MDR
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Delve into the challenges that Notified Bodies and industry are experiencing during the transition from MDD to MDR. Glean expertise from the industry’s early adopters with real-world examples
On-demand On-demand
IVDR 2022: What IVD manufacturers can learn from the MDR rollout
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will cover the potential impact of IVDR implementation in 2022 for new and existing (legacy) devices and considerations learned from the MDR rollout for IVD manufacturers to consider strategy.
On-demand On-demand
China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will explore the evolving regulations for China NMPA, reviewing regulations related to clinical evaluation, the main changes under Decree #739 in areas of clinical evaluation pathways.
     
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