Regulatory NewsRegulatory News
Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicants
Posted 06 July 2022 By Jeff Craven
Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval after submission compared to batch manufacturing products, according to results from a US Food and Drug Admi...
Regulatory NewsRegulatory News
FDA approval lowers, but doesn’t eliminate disparities in immunotherapy use
Posted 30 June 2022 By Jeff Craven
Racial, ethnic and sociodemographic disparities that are present in clinical trials and compassionate use agreements for cancer immunotherapy during the pre-approval period are reduced, but not eliminated after the US Food and Drug Admin...
Regulatory NewsRegulatory News
RWD in clinical trials: External control arms take the lead
Posted 23 June 2022 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) has now published four draft guidances spelling out how it will consider real-world data (RWD) in regulatory decision-making, from the use of electronic health records and registries to RWD in no...
Regulatory NewsRegulatory News
Expert proposes changes to accelerated approval reforms in user fee bills
Posted 08 June 2022 By Jeff Craven
With the Senate Committee on Health, Education, Labor and Pensions (HELP) recently releasing the Food and Drug Administration Safety and Landmark Advancements (FDASLA) act from committee, some stakeholders are proposing Congress make cha...
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
Study: Breakthrough designated drugs led to better clinical outcomes for patients with NSCLC
Posted 31 May 2022 By Jeff Craven
Drugs granted a breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) were more likely to yield better outcomes for patients with non-small cell lung cancer (NSCLC) compared with drugs that didn’t carry the ...
Regulatory NewsRegulatory News
MDCG sets out transition periods for legacy diagnostics post-IVDR
Posted 24 May 2022 By Gareth Macdonald
The European Commission’s Medical Device Coordination Group (MDCG) has clarified how long legacy devices can remain on the market after the In Vitro Diagnostic Regulation (IVDR) comes into application.
This Week at FDAThis Week at FDA
Regulatory NewsRegulatory News
This Week at FDA: House advances user fee bill, FDA’s enterprise modernization ambitions, and another 510(k) pilot
Posted 20 May 2022 By Michael Mezher
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. It was a busy week for FDA on the Hill again, wit...
Virtual Programs Virtual Programs
Tackling the CMC Challenges for Cell and Gene Therapy Product Development
Wednesday, 03 August 2022 (12:00 - 2:00PM) 2.0 RAC Credits Price: Member: $195 / Nonmember $230
Key opinion leaders from academia, industry, and a regulatory agency will discuss these strategies in addressing CGT manufacturing challenges to bring transformative medicines to patients.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Postmarket Surveillance [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course highlights the requirements and importance of an effective postmarket surveillance program that satisfies the regulatory and quality system requirements in the US, Canada and Europe.
Books Books
Lifecycle Management Through the Rx-to-OTC Switch
Member: $145.00 Nonmember: $200.00
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.
On-demand On-demand
How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review the application of a modern approach to risk management as a product moves through the product lifecycle.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Introduction to Regulatory Affairs in the EU [1.0 RAC]
1.0 RAC Credits
Member: $135.00 Nonmember: $185.00
This course focuses on the development of healthcare product regulation in the European Union (EU). It discusses the responsibilities of agencies involved, processes employed and interactions among agencies.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulatory Due Diligence for Product Development [3.0 RAC]
3.0 RAC Credits
Member: $365 Nonmember: $500
This course will provide a basic understanding of the principles and practices of due diligence within the medical product environment.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of US & EU Biologics [5.0 RAC]
4.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course examines the special characteristics of biologic products and the challenges associated with their development in the US and EU.
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.
     
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