Regulatory NewsRegulatory News
FDA blasts California firm for multiple GLP issues involving nonclinical studies
Posted 11 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) found a slew of good laboratory practice (GLP) violations during the conduct of nonclinical studies at West Sacramento, CA firm Valley Biosystems in a 3 August warning letter and blasted the fi...
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
FDA issues Jynneos EUA to stretch monkeypox vaccine supply
Posted 09 August 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Bavarian Nordics’ monkeypox vaccine Jynneos to be administered to adults intradermally. The move is meant to significantly increase the availabili...
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The pharmaceutical industry is calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on radiolabeled mass balance studies, suggesting the guidance be revised to require fewer subjects, and mention a male prefe...
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...
Regulatory NewsRegulatory News
Manufacturers that are not testing DSCSA data systems now are in 'big trouble'
Posted 08 August 2022 By Joanne S. Eglovitch
While much progress has been made by trading partners in implementing the pharmaceutical tracking systems called for in the Drug Supply Chain Security Act (DSCSA) more work needs to be done to ensure a smooth transition when these syst...
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
EPA lists potentially high-risk EtO plants, plans to finally publish air pollution rule by year’s end
Posted 03 August 2022 By Ferdous Al-Faruque
The US Environmental Protection Agency (EPA) has published a list of ethylene oxide (EtO) sterilization plants around the country that may be linked to increased cases of cancer in nearby communities. The agency also plans to publish a...
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Software as a Medical Device
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Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.
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Effectively Coping with the European IVD Regulation
Tuesday, 18 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 1080 | Nonmembers: € 1,264
Although much is clear in the IVD-R text, as the saying goes "the devil is in the details" and there are lots of areas still open to interpretation and which need further guidance.
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Cybersecurity
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Gain the knowledge you need to navigate global cybersecurity expectations, translate regulatory expectations into concrete design and development activities and establish trust with customers.
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China Drug Market Opening Up for Foreign Drug Makers
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This virtual program will provide regulatory professionals with helpful information, strategies, and insights about drug registration with China NMPA.
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Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions
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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.
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FDA Forecast: What’s Next for the FDA in 2022? (On-Demand)
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Meet the Authors, Regulatory Intelligence 101, Third Edition
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The three leading authors will answer your questions on why this book needed to be revised and why all regulatory intelligence (RI) professional can benefit from this update.
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Learn to Comply With China's UDI Submissions Requirements
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Overview of key UDI-related regulations, lessons learned from the first batch pilot, and guidance on how to comply with requirements.
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Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.
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Understanding and Applying FDA’s 510(k) Modifications Guidance
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This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
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Purity is a Virtue: A Practical Guide to the Reporting of Impurities
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Increase your understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take-away messages.
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A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
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Sponsored Webcast: FDA QMSR: What do the Proposed Changes Mean for Industry?
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Speakers will review the history of quality systems, look at the changes to quality regulations and discuss the FDA’s intent to adopt the ISO 13485 standard.
     
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