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Warning Letters Special Report: What Worried The FDA Most About Pharmaceutical Supply Chains

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.

Quality Enforcement

Warning Letters Special Report: Where Investigations By Prescription Drug Product Firms Fell Short

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.

Quality Enforcement

Warning Letters Special Report: Why Investigations Once Again Led Drug GMP Problem Areas In 2022 And What To Do About It

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.

Quality Enforcement

Warning Letters Special Report: Top Problem Areas Were Investigations, Testing And Sterility

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.

Quality Enforcement

Warning Letters Special Report: The Full List

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

Quality Enforcement

Warning Letters Special Report: Pandemic Drove Focused Inspections, Alternative Approaches

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.

Quality Enforcement

Fastest Ever Review For A Product In EMA's PRIME Scheme

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.

Europe Review Pathway

The Evolution Of Drug Regulation In Post-Brexit Britain

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.

United Kingdom Approvals

Decentralized Clinical Trials ‘No Longer A Leap Of Faith’

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.

International Pink Sheet Perspectives

‘Decentralized Clinical Trials 2.0’ On The Horizon

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. 

Pink Sheet Perspectives Clinical Trials

Hot Spots In 2023: US FDA Goal Dates Portend Battles In Diseases From RSV To Ulcerative Colitis

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.

US FDA Performance Tracker Pink Sheet Perspectives

Bountiful Approvals May Be Ahead As FDA Starts 2023 With Almost 60 Novel Agents Under Review

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.

Pink Sheet Perspectives US FDA Performance Tracker
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