In today’s regulatory climate, avoiding an FDA Form 483 after an inspection isn’t necessarily a sign of success, it’s the bare minimum. True industry leadership in Current Good Manufacturing Practice (cGMP) goes beyond damage control. It demands a proactive, risk-based approach to quality that starts well before the regulator arrives for an inspection. The finalization of […]
While paper trails and legacy systems remain part of the landscape, pharma has been actively coding its next chapter: evolving through digital innovation, transforming core functions like drug development, manufacturing, regulatory oversight, and patient interaction. Central to this is the adoption of advanced technologies such as artificial intelligence (AI), blockchain, cloud computing, and digital twins, […]
The AI Action Plan was initiated by Executive Order (EO) 14179, signed in January 2025, which directed the federal government to remove barriers to AI innovation and develop a national strategy. Following a public consultation that generated over 10,000 comments, the plan was released in July 2025 with input from industry, academia, and government stakeholders. […]
A recent report in Nature Medicine (published February 17, 2025) highlights the long-term potential of Chimeric Antigen Receptor T Cell products (aka CAR-T cell therapy), showcasing an exceptional 18-year remission in a neuroblastoma patient. This milestone is particularly significant given the historical challenges that CAR-T therapy has faced in effectively treating solid tumors like neuroblastoma, even while […]
The pharmaceutical industry is entering a transformative era with the Food and Drug Administration’s (FDA) newly established pathway for nonprescription drug products with an Additional Condition for Nonprescription Use (ACNU), with the final rule announced in a December 2024 Federal Register Notice (here). This new rule aims to broaden consumer access to safe and effective […]
