ReconRecon
Recon: PhRMA weighs legal options as US pricing reforms move through Congress; Europe to consider dose-sparing to increase monkeypox vaccine
Posted 11 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA Official: EU privacy regulations impede BIMO inspections, application reviews
Posted 10 August 2022 By Ferdous Al-Faruque
According to a US Food and Drug Administration (FDA) lawyer, the European Union’s privacy regulations are a headache for researchers and regulators trying to share data. Heather Messick, the former lead policy analyst on the EU’s General...
Regulatory NewsRegulatory News
Study: Accelerated approval pathway working as intended in most cases
Posted 10 August 2022 By Jeff Craven
Over the last several decades, the US Food and Drug Administration’s (FDA) accelerated approval program has largely been working as it was designed to, with about half the products using the pathway being converted to traditional approva...
Regulatory NewsRegulatory News
Drugmakers request changes to FDA’s mass balance studies guidance
Posted 09 August 2022 By Joanne S. Eglovitch
The pharmaceutical industry is calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on radiolabeled mass balance studies, suggesting the guidance be revised to require fewer subjects, and mention a male prefe...
ReconRecon
Recon: Pharma industry laments Senate drug pricing bill; GSK, Mersana sign $1.4B preclinical ADC deal
Posted 09 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Senate passes major drug pricing reforms; Pfizer to buy Global Blood Therapeutics for $5.4B
Posted 08 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: EtO, user fee woes, and product specific guidances
Posted 05 August 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 Environmental Protection Agency (EP...
Regulatory NewsRegulatory News
Califf seeking Congressional assurance user fees won’t run out
Posted 01 August 2022 By Ferdous Al-Faruque
With only two months to go before user fee legislation runs out and no indication Congress will reauthorize it in time, FDA Commissioner Robert Califf sought to assure agency staff that he is doing his best to get ascertain from lawmaker...
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.
Virtual Programs Virtual Programs
Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development
Thursday, 22 September 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $0
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
Virtual Programs Virtual Programs
Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions
Wednesday, 05 October 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | NonMember: $0
This session will cover a comprehensive analysis of the Accelerated Approval program as well as a deep dive into a selection of past examples and precedents.
On-demand On-demand
The COVID-19 Impact: How will Regulatory Emerge from the Pandemic?
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn how regulatory teams are adapting to this global health crisis and what effects it will have in the short and long term.
Books Books
Regulatory Intelligence 101, Third Edition
Member: $130.00 Nonmember: $180.00
Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.
Books Books
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Member: $160.00 Nonmember: $225.00
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
On-demand On-demand
Sponsored Webcast: eCTD Submission Challenges (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.
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.
On-demand On-demand
Regulatory Policy & Intelligence: Understanding When, Why, and How to Invest in Growing These Capabilities
1.0 RAC Credits
Member: $0 Nonmember: $20
Industry-leading regulatory experts will provide practical insights on how to assess RI needs, why this area is worth the investment, and how to build an RI strategy that fortifies the unique objectives of your company.
Books Books
Promotion of FDA-Regulated Medical Products
Member: $130.00 Nonmember: $180.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
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.
     
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