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...
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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...
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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.
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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.
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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...
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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.
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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.
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China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19
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Key Regulatory Topics: eCTD
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eCTD guidance documents from the ICH, EMA, and FDA.
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Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD
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A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
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Quality Management Systems for Drugs and Devices (e-book)
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Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
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EU Regulatory Acronyms & Definitions, Sixth Edition
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An EU reference guide with entries in biologics, medicinal products, and medical devices.
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International Regulatory Acronyms & Definitions, Third Edition
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International regulatory terms, definitions, and acronyms that will help you develop a better understanding of international regulations.
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Canadian Regulatory Acronyms & Definitions, Fifth Edition
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For those working in the Canadian market, entries of significance to the Canadian healthcare product industry.
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Terms & Definitions of Japanese Regulatory Affairs
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English translations of the most important Japanese regulatory terms and acronyms.
     
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