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Bowman Cox

Executive Editor

Washington, DC
Bowman Cox leads the Pink Sheet's coverage of pharmaceutical manufacturing quality issues. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to drug manufacturers and their quality organizations.
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Latest From Bowman Cox

FDA Pilot Finds That Advance Records Yield More Inspection Findings

When FDA piloted the use of Section 706 authority to obtain records in advance of inspection, the US agency found the results included more inspection findings but not quicker inspections.

Compliance Manufacturing

FDA Mulls Which EU Inspections To Skip Under EU MRA

As US FDA sets its FY 2018 inspection priorities, it is considering whether there are recent or upcoming inspections by inspectorates in eight European countries recognized under a US/EU mutual recognition agreement that it could rely on instead, agency official says. Over time, FDA could rely more on EU inspection priorities.

Compliance Manufacturing

Will Continuous Manufacturing Mean Continuous Generic Delay? FDA Hears AAM's Warning

Association for Accessible Medicines calls for US FDA to guard against use of continuous manufacturing methods to protect brand drugs from batch-manufactured generic drugs that may be of lower but still acceptable quality. Then FDA approves first generic of a continuously manufactured drug.

Manufacturing Quality

Hurricane Maria Tests Pharma Business Continuity Plans

Puerto Rico's slow recovery from Hurricane Maria provides insight into what happens when disaster strikes a node of the global pharmaceutical manufacturing network. Initial efforts to ward off US drug shortages focus on generic injectables that can't support expensive business continuity plans – but even critical prescription brands could be threatened if the US territory's power grid remains off line too long.

Manufacturing Scrip 100

Lawsuit, Warning Letter Mark Return Of B. Cepacia As GMP Issue

Lawsuit over infant's death and warning letter over recurring contamination underscore the importance of screening for Burkholderia cepacia and when found, removing the microorganism from pharmaceutical manufacturing processes.

Quality Compliance

FDA Warns Lupin To Stop Blaming Lab And Fix Manufacturing Processes

Warning letter points to excessive in-process hold times as likely cause of out-of-specification results at two Lupin plants that the firm dismissed as outliers or blamed on analysts. FDA directs Lupin to eliminate excessive hold times and study whether they were problem.

Approvals FDA
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