Regulatory NewsRegulatory News
FDA clarifies reporting post-approval changes for disposable manufacturing materials
Posted 01 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) on Friday issued a question-and-answer guidance  to provide clarity to manufacturers on reporting post-approval changes to disposable manufacturing material.  
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
FDA warning letter tells Spanish API firm to up its validation game
Posted 22 July 2022 By Joanne S. Eglovitch
A Spanish producer of active pharmaceutical ingredients (API) was chastised by the US Food and Drug Administration (FDA) in a June 30 warning letter for its spotty approach to validation and ensuring that manufacturing processes remain...
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US Food and Drug Administration (FDA) for clarification related to the evaluation of cellular starting materials in its draft guidance on chimeric antigen receptor (CAR) T cell product development.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 finalizes guidance on food effect studies, issues draft on contamination prevention for non-penicillin beta-lactam drugs
Posted 27 June 2022 By Jeff Craven
The US Food and Drug Administration (FDA) recently issued two guidances for industry: a final guidance on how to conduct food effect studies for oral drugs being considered for investigational new drug (IND) and new drug applications (ND...
RoundupsRoundups
Asia-Pacific Roundup: PMDA outlines changes to project focused on medicine use in pregnancy
Posted 14 June 2022 By Nick Paul Taylor
Officials created the Japan Drug Information Institute in Pregnancy (JDIIP) in 2005 to collect and review the latest evidence on the effects of medicines on mothers and fetuses. Using the insights, the institute provides consultations fo...
Regulatory NewsRegulatory News
Experts say FDA enforcement focus unchanged, use of alternative tools to grow
Posted 01 June 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) will continue to focus on data integrity practices and take a hard look at OTC firms’ testing programs either through onsite inspections or using alternative inspection tools in fiscal year 2022,...
Regulatory NewsRegulatory News
FDA asks manufacturers to develop risk management plans to avert shortages
Posted 20 May 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drug and medical devices are vulnerable to shortages and should be subject to risk management plan (RMP) reporting. The guidance also reco...
     
  •  
  • 1
  •  
  • 2
  •  
  • 3
  •  
  • 4
  •  
  • 5
  •  
  •  
Virtual Programs Virtual Programs
China Drug Market Opening Up for Foreign Drug Makers
Tuesday, 16 August 2022 (11:00 - 12:30PM) 1.0 RAC Credits Member: $150 | NonMember: $175
This virtual program will provide regulatory professionals with helpful information, strategies, and insights about drug registration with China NMPA.
On-demand On-demand
CMC - An Integral Component of Cell and Gene Therapy Development
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Chemistry, Manufacturing and Controls (CMC) [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides an overview of the CMC section of dossiers.
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.
E-books E-books
Orphan Drug Development for Rare Diseases (e-book)
Member: $130.00 Nonmember: $180.00
Orphan Drug Development for Rare Diseases covers every aspect of orphan drug development. Topics include incentives, benefits, patient engagement, designation, marketing authorization, and market access.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Combination Products [3.0 RAC]
3.0 RAC Credits
Member: $365 Nonmember: $500
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
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.
Books Books
Key Regulatory Topics: eCTD
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
     
  •  
  • 1
  •  
  • 2
  •  
  •  

All Results

On-demand On-demand

CMC - An Integral Component of Cell and Gene Therapy Development

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Chemistry, Manufacturing and Controls (CMC) [5.0 RAC]

5.0RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides an overview of the CMC section of dossiers.