The U.S. government shutdown has finally ended, and for the FDA, the relief is real. With Congress passing a funding bill covering the agency through September 30 of the next fiscal year, the agency now [...]

The start of October 2025 brought an unusual complication for the life sciences industry - a partial U.S. government shutdown that has significantly limited FDA operations. With much of the agency’s staff on furlough and [...]

The combination products sector is an exciting intersection of drugs, devices, and biologics, offering immense potential to revolutionize healthcare. However, with this potential comes a uniquely challenging regulatory environment. The complex landscape of global regulations [...]

The journey of developing and commercializing combination drug/device products is filled with challenges, primarily due to the non-harmonized global regulatory frameworks. As discussed at the recent 2023 Combination Products Summit, manufacturers face significant hurdles because [...]

Leading the Way in Life Sciences Compliance and Quality Management Quality Solutions Now (QSN) and ComplyFDA have joined forces to offer unparalleled solutions in quality management and regulatory compliance for the life sciences industry. This [...]