<span class="archive__title-prefix>Posts Categorized:</span> Conference Spotlight

Recent discussions about FDA departmental changes and budget cuts have raised concerns across the life sciences industry and among American consumers. As the agency responsible for ensuring drug safety, preventing counterfeit products, and maintaining market integrity, any reduction in FDA oversight could have far-reaching consequences, not just for industry stakeholders but for patients who rely […]

At the PDA/FDA Joint Regulatory Conference 2024 held in Washington, DC, September 9-11, 2024, FDA Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Office of Pharmaceutical Manufacturing Assessment (OPMA) Senior Pharmaceutical Quality Assessor Dr. Madu Dharmasena provided her insights on CDER’s regulation of biologics products. In addition to its responsibility for […]

Common questions across the pharma industry since the business model shifted years ago to contracting out manufacturing and supply chain operations include, “Who is responsible when current Good Manufacturing Practice (CGMP) regulations are not followed? Which entity is subject to enforcement actions by regulatory agencies including 483s and warning letters?” Those questions were explored by […]

Did you know that FDA sometimes holds regulatory meetings to discuss a Voluntary Action Indicated (VAI) or Official Action Indicated (OAI) inspection outcome with the inspected drug manufacturer? What is the purpose of these meetings and how do they differ from one another and other regulatory meetings? While many are familiar with the Types A, […]

At the PDA/FDA Joint Regulatory Conference 2024 held in Washington, DC, September 9-11 2024, Associate Commissioner of Regulatory Affairs (ACRA) in the FDA Office of Regulatory Affairs (ORA), Michael Rogers discussed his office – which will be renamed Office of Inspections and Investigations on October 1 – and the attrition FDA has been experiencing in […]

How does an expert FDA investigator conduct a manufacturing inspection? While each inspection and each investigator is different, what thought processes might they use as they walk through a facility? At the 48th annual International GMP Conference held in early March 2024 at the University of Georgia in Athens, Georgia, FDA national expert pharmaceutical investigator […]

Blatant data manipulation – for example, falsifying visual inspection particle counts for finished parenteral products – was highlighted in a Form 483 from a 2023 drug manufacturing facility inspection. In addition, observations from a different 2023 inspection cataloged egregious data integrity lapses, including the use of shared passwords and erasable markers to record GMP data. […]

What actions should a pharma company take upon receiving a form 483 from FDA after a manufacturing facility inspection? What are key elements in submitting a response to the 483 that the agency will find acceptable? How important are these actions in avoiding additional enforcement actions by FDA? At the 48th annual International GMP Conference […]

In September 2022, an FDA inspection found that a company in Puerto Rico had released numerous batches of an infusion product – i.e., destined to be put directly into the human bloodstream – even though microbiological plate testing showed the product contained high levels of a microbiological contaminant, designated Too Numerous to Count (TNTC). The […]

How does Health Canada conduct regulatory compliance and enforcement? What different offices carry out its compliance and enforcement function? Health Canada’s Regulatory Operations and Enforcement Branch (ROEB) is responsible for oversight and inspections to ensure compliance with acts and regulations. It conducts inspections, compliance verifications, product sampling, enforcement measures, and investigations. The Regulatory Operations and […]