Regulatory NewsRegulatory News
Accelerated Approval: Experts weigh in on the role of RWE in confirmatory trials
Posted 08 August 2022 By Mary Ellen Schneider
As Congress considers how to reform the US Food and Drug Administration’s (FDA) controversial pathway for providing accelerated approval to drugs that treat serious or life-threatening diseases, there may be an expanded role for real-wor...
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
Neonatal drug development addressed in FDA final guidance
Posted 27 July 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) issued final guidance this week to assist sponsors in developing clinical pharmacology studies for neonatal populations. The guidance is meant to address gaps in neonatal labeling and encourage...
Regulatory NewsRegulatory News
FOCR offers path for validating ctDNA as an early endpoint for drug approval
Posted 25 July 2022 By Mary Ellen Schneider
Friends of Cancer Research (FOCR) has issued an evidentiary roadmap for validating circulatory tumor DNA (ctDNA) as an early endpoint for accelerated drug approval in solid tumors, spelling out a strategy for generating the data needed t...
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
Califf: ‘Enormous’ implications for FDA if user fee programs are not reauthorized
Posted 12 July 2022 By Michael Mezher
In a tumultuous year coinciding with the agency’s five-year user fee reauthorization cycle, US Food and Drug Administration (FDA) Commissioner Robert Califf discussed his priorities for the agency and what happens if its user fee program...
Regulatory NewsRegulatory News
Drugmakers seek details on use of ctDNA as a biomarker or early endpoint
Posted 07 July 2022 By Mary Ellen Schneider
Drug developers are asking the US Food and Drug Administration (FDA) for more details on definitions, methodologies, and use cases for employing circulating tumor DNA (ctDNA) as a biomarker or an early endpoint in early-stage solid tumor...
Regulatory NewsRegulatory News
Oligonucleotides: FDA drafts clinical pharmacology guidance
Posted 27 June 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) last week issued draft guidance spelling out its expectations for the types of clinical pharmacology assessments that should be conducted during the development of oligonucleotide therapies. The ...
On-demand On-demand
Sponsored Webcast: Smarter Clinical Document Automation Now for your T&D Requirements Later (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webcast will illustrate how automation through the use of advanced technology allows for the production of clinical documents with future disclosure in mind.
On-demand On-demand
The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment
1.0 RAC Credits
Member: $0 Nonmember: $20
This webcast will not try to predict how the geopolitical world will change as a consequence of COVID-19, but will cover current hot topics and emerging challenges affecting regulatory affairs professionals globally.
On-demand On-demand
Most Common Findings in EU Clinical Evaluations
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the most common findings identified by Notified Bodies and by Qserve when performing a final CER review to the requirements of the MDR and MEDDEV 2.7/1 rev.4.
Books Books
Complete WHO Guidance Documentation Bundle
Member: $15.00 Nonmember: $22.50
A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
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]
3.0 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.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Definition & Lifecycle [1.0 RAC]
1.0 RAC Credits
Member: $135.00 Nonmember: $185.00
This course also provides an introduction to the lifecycle of drug products, from discovery to on-market support.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Canadian Regulations [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course will provide a basic understanding of medical device regulations in Canada.
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.
     
  •  
  • 1
  •  
  • 2
  •  
  • 3
  •  
  • 4
  •  
  •