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Khelin N. Aiken

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Khelin Aiken practices in the area of US Food and Drug Administration regulatory and compliance law. She leverages her deep understanding of the US Food Drug & Cosmetic Act, US Public Health Service Act and their implementing regulations along with her prior experience at the US Food and Drug Administration (FDA) to help clients develop and achieve their strategic business objectives. Khelin previously served as regulatory counsel at the FDA in the Center for Drug Evaluation and Research, in both the Office of Regulatory Policy and in the Office of New Drugs with the Therapeutic Biologics and Biosimilars Staff.

In brief On 22 October 2020, the FDA approved the anti-viral drug Veklury (remdesivir) for hospitalized COVID-19 patients, making it the first drug to receive approval for the treatment of COVID-19. Before approving this drug, the FDA issued an Emergency Use Authorization for the use of Veklury in COVID-19 treatment. We will…

FDA Food Safety Modernization Act Proposed Rule to Advance Traceability of Foods Key Takeaways On September 23, 2020, the Food and Drug Administration (FDA, the Agency) released its proposal to establish additional recordkeeping requirements for those that manufacture, process, pack, or hold foods on the Food Traceability List by collecting…

With the healthcare and life sciences sector at the heart of the pandemic, we are seeing some new issues arising in the already complex world of life sciences collaborations, for both coronavirus-related and other products and therapies. The Life Sciences Collaborations: Key Considerations in the COVID-19 Era document is a…

Key Takeaway It is vital for manufacturers of market-critical drug products to survey their supply chain and current available product supply to ensure compliance with reporting requirements. Further, while FDA inspections of manufacturing facilities in China are currently not taking place, the FDA has increased import sampling and screening in…