Pink Sheet Perspectives

One in five of the drug GMP warning letters the US FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became a major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. The year also featured a pair of warning letters to excipient firms, one a Mexican glycerin supplier, and the other a unit of DuPont.

Warning letters examined in part five of our in-depth report showed how prescription drug firms got into trouble with the US FDA in 2022 by conducting investigations that were too narrow and that failed to trigger appropriate corrective actions. Several firms failed in their sterile injectables contamination investigations. Other inquiries failed to establish proper control of tablet and capsule manufacturing.

In this fourth installment of our in-depth series, the Pink Sheet reports that inadequate investigations topped the list of problem areas cited in US FDA 2022 drug GMP warning letters. Experts share key pointers on investigating complaints, OOS results, nonconformances and deviations.

Drug GMP warning letters last year cited testing inadequacies and poor batch failure and complaint investigations more than any other problem, this third part of our in-depth series reports, followed by sterility assurance issues that were somewhat driven by concerns about water systems. Most were US-focused – a pandemic limitation but also a reminder that drug GMP problems are not limited to China and India.

All 82 drug GMP warning letters the FDA issued in 2022 are listed and categorized in this interactive table.

In the first part of our in-depth series, the Pink Sheet outlines how 2022 warning letters reflected agency’s efforts to overcome COVID-19 travel restrictions. As pandemic abates, a new, less inspection-intensive normal could emerge.

The European Medicines Agency says that when it comes to products developed under its priority medicines scheme, dialog is crucial to ensure that the data generated for marketing applications are sufficiently robust and mature and facilitate a timely review.

Regulatory reliance is playing an increasingly important role in gaining marketing authorization in the UK following Brexit. Meanwhile, the country’s unique Innovative Licensing and Access Pathway is attracting growing levels of interest, not just from companies but from regulators and health technology appraisal bodies across the world.

This second segment of a two-part Pink Sheet article on decentralized clinical trials looks at ensuring that staff at study sites are on onboard to support fast-paced change in this field, how regulatory guidance can help tackle hesitancy, and the need to transparently track such studies.

The remarkable shift towards decentralized clinical trials in the last three years is a testament to how this patient-centric approach of doing research has the potential to solve multiple issues such as time, cost and low participation rates. In this first segment of a two-part article, the Pink Sheet looks at how innovation in this sector has just begun and we can expect more action ahead. 

Novel agents targeting similar indications suggest potential commercial struggles across the therapeutic landscape, with battlegrounds taking shape between RSV vaccines, new mechanisms in major depression, and bispecifics for large B-cell lymphoma.

The upcoming year could see a rebound approvals if the bigger-than-usual queue of novel agents with 2023 user fee goal dates pans out.