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
Legal Expert: Too early to tell if SCOTUS ruling will chill FDA regulation
Posted 09 August 2022 By Ferdous Al-Faruque
When the majority of the US Supreme Court (SCOTUS) in late June said that an Obama-era Environmental Protection Agency (EPA) policy to curb climate change was a regulatory overreach, legal experts wondered if it would have a chilling eff...
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
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...
ReconRecon
Recon: Senate Democrats agree on $430 billion reconciliation bill with drug pricing measures; Cassava faces criminal probe over falsified data for Alzheimer's drug
Posted 28 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Biogen nabs priority review for ALS therapy, despite phase 3 miss; Pfizer, BioNTech file US suit against CureVac
Posted 26 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Books Books
The European In Vitro Diagnostic Regulation
Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
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.
On-demand On-demand
Building Global Submissions from the Ground Up - SARS-CoV-2 Case Study
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Whether you are developing SARS-CoV-2 assays or are just interested how to efficiently build your global submissions, this webcast aims to share some of those best practices using SARS-CoV-2 as a case study.
Books Books
Eclectic Science and Regulatory Compliance: Stories for the Curious
Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
Books Books
Communication and Negotiation
Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
Books Books
Choosing the Right Regulatory Career
Member: $20.00 Nonmember: $25.00
Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.
On-demand On-demand
China NMPA Medical Device Latest & Most Important Policy: Key Highlights of Order 739
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Review the key highlights of this new policy and the implications for overseas companies in premarket submission clinical and technical requirements, innovation focus, MAH and post market changes.
On-demand On-demand
China NMPA (CFDA) Regulatory Approval: Clinical Evaluation and Pathways
6.0 RAC Credits
Member: $480.00 Nonmember: $540.00
This workshop will cover different clinical evaluation and pathways and how to decide which pathway to choose to support China NMPA medical device/IVD regulatory approval or postmarket study requirements.
     
  •  
  • 1
  •  
  • 2
  •  
  • 3
  •  
  •