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
FDA announces website for complex generics
Posted 05 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development.  
Regulatory NewsRegulatory News
FDA clarifies reporting post-approval changes for disposable manufacturing materials
Posted 01 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) on Friday issued a question-and-answer guidance  to provide clarity to manufacturers on reporting post-approval changes to disposable manufacturing material.  
Regulatory NewsRegulatory News
Neonatal drug development addressed in FDA final guidance
Posted 27 July 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) issued final guidance this week to assist sponsors in developing clinical pharmacology studies for neonatal populations. The guidance is meant to address gaps in neonatal labeling and encourage...
Feature ArticlesFeature Articles
The impact of Brexit on food supplements and specialized food products
Posted 27 July 2022 By Sam Jennings, BSc, FIFST
This article examines the impact of diverging regulations and practices for food supplements and specialized food products since the UK left the EU market in 2020.   Keywords – Brexit, divergence, food supplements, UK, Northern Ire...
Regulatory NewsRegulatory News
FDA describes plans to expand remote regulatory assessments
Posted 22 July 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as it eases out of pandemic ...
Regulatory NewsRegulatory News
FDA warning letter tells Spanish API firm to up its validation game
Posted 22 July 2022 By Joanne S. Eglovitch
A Spanish producer of active pharmaceutical ingredients (API) was chastised by the US Food and Drug Administration (FDA) in a June 30 warning letter for its spotty approach to validation and ensuring that manufacturing processes remain...
Regulatory NewsRegulatory News
Pharmaceutical industry groups suggest modifications to ICH Q9 guideline
Posted 19 July 2022 By Joanne S. Eglovitch
Pharmaceutical industry groups in the US suggested the International Council of Harmonization’s (ICH) Q9(R1) guideline on risk management be revised to better reflect the principles of the ICH Q10 guideline on effective quality managemen...
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Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development
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Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions
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Meet the Author, International Combination Products, First Edition
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Risk Management Principles for Devices and Pharmaceuticals
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Expanded and updated risk management information on healthcare products around the world.
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21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices
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The RAPS Philadelphia Chapter’s webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices.
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CMC - An Integral Component of Cell and Gene Therapy Development
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Experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies.
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A Risk-Based Approach to Validation for Life Sciences Companies
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Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements (On-demand)
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Efficiency and Technology Pave the Way for the New Age of Narrative Writing
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