Category Archives: FDA Enforcement Trends

Deep Pockets | Does the FDA Get Tougher if the Owner Gets Richer?

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in many functional areas.  Let’s talk about activities in the GMP area.  Firms may not be able to fully rely on past inspections by the FDA to predict the extent of remediation that might be necessary in the manufacturing and testing of the firm’s products.  We provide five recent examples where the FDA appears to increase their enforcement intensity when an acquiring firm with perceived ‘deep-pockets’ enters the game.

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The Heightened Importance of Contract Manufacturing Organizations

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

One of the most thought-provoking presentations at the recent PDA / FDA meeting in Washington DC was given by Guy Villax, CEO of Hovione Pharmaceuticals.  Hovione Pharmaceuticals offers a range of contract services including but not limited to, product development, manufacturing of API and drug products, and analytical support.  Guy’s presentation was one of two on the opening day that addressed ‘Current Quality Challenges for Pharmaceutical Executives.’  He began his talk by saying that 60% of small molecule APIs for new NDAs are made by contract manufacturers.  I was surprised by the figure.  This is clearly different than practices of 15-20 years ago and, according to Guy, represent a migration of CMC knowledge to CDMOs.  That alone calls for us to re-evaluate the relationship between CDMO and sponsor firms, particularly for the virtual firms.

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