The inability to conduct onsite inspections impeded investigators’ ability to uncover data integrity issues at manufacturing sites in drug warning letters in FY2021, underscoring the importance of ...

The US Food and Drug Administration (FDA) has warned an active pharmaceutical ingredient (API) maker in India for falsifying manufacturing records and issued a warning letter to a contract testing lab ...

Increased regulatory focus on data integrity violations in GxP inspections opens opportunities for pharma companies to invest in staff training and compliance strategies related to document management ...

Evolving regulatory expectations in clinical research create opportunities in risk-based governance, data integrity, and digital process integration. Focus on technology-driven trials, vendor ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

Clinilabs (“Clinilabs LLC”), a global, full-service contract research organization (CRO) specializing in CNS drug and device development, today announced it has successfully completed an inspection by ...

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...

Fresh concerns have emerged about the platelet studies underpinning the FDA approval of ticagrelor, AstraZeneca's multibillion-dollar heart drug. A new BMJ investigation reveals data discrepancies, ...

The course provides opportunities to enhance knowledge of cGMPs and GLPs, essential for compliance in QC labs across industries, such as pharmaceuticals and cosmetics. It helps attendees understand ...

From drug safety testing to AI-enabled medical devices, ethical and regulatory standards are the backbone of trustworthy science. Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and ...

Morepen Labs' Masulkhana facility clears US FDA inspection with Zero adverse observations: Our Bureau, Mumbai Tuesday, April 21, 2026, 13:30 Hrs [IST] Morepen Laboratories Limited ...