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FDA chastises three US firms for ignoring record requests, inadequate CMO oversight, and shoddy response to fires
Posted 21 October 2021 By Joanne S. Eglovitch
Inadequate oversight of contract manufacturers, failing to address how a fire affected the quality of active pharmaceutical ingredients, and ignoring the agency’s request for electronic records prompted the US Food and Drug Administratio...
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EC updates Clinical Trial Regulation Q&As ahead of January go-live
Posted 18 October 2021 By Joanne S. Eglovitch
The European Commission has issued an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (CTR), which is set to go into effect this January.  
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WHO seeks input on medicines to prioritize for BCS-based biowaivers
Posted 27 September 2021 By Michael Mezher
The World Health Organization (WHO) is seeking input on the fourth set of medicines to prioritize for biopharmaceutics classification system (BCS)-based biowaivers to ease in vivo study requirements for generic drugs.
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Perrigo: Pharmaceutical industry should question nitrosamine risk assessments
Posted 31 August 2021 By Joanne S. Eglovitch
The pharmaceutical industry needs to closely evaluate suppliers’ testing to ensure that accurate methods are being used to assess nitrosamine risks in drug products. Not questioning dubious results can wreak havoc and unnecessarily flag ...
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Antifreeze and APIs don't mix, FDA tells Syntec
Posted 03 August 2021 By Joanne S. Eglovitch
The US Food and Drug Administration has warned New York - based pharmaceutical manufacturer Syntec for a litany of good manufacturing practice (GMP) problems. The agency says that issues related to how the firm handles active pharmace...
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FDA declines to extend nitrosamine risk assessment deadline
Posted 26 July 2021 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) rejected pleas from the pharmaceutical industry to extend the deadline for conducting nitrosamine risk assessments to 1 September, standing firm on the 1 March deadline.  
Recon: BioNTech buys production site, T-cell platform from Gilead; China approves AstraZeneca’s Imfinzi for aggressive form of lung cancer
Posted 19 July 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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EMA updates Q&A on nitrosamine assessment and testing
Posted 07 July 2021 By Joanne S. Eglovitch
The European Medicines Agency (EMA) has published an updated “question and answer” guidance describing how manufacturers should assess the risk of nitrosamine impurities in drug products and how to test products for these impurities.  
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RAC Drugs Examination Autumn 2022

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RAC Drugs Examination Spring 2022
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