At FDA, Looks Like 'Transparency' is Word of the Year

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Patrick Stone, President, TradeStone QA

Regulated health care industry professionals routinely request more guidance and transparency from regulators. New mandates for FDA have pushed modernization in an effort to promote transparency in government.

The FDA’s responses to this modernization request are the following FDA’s Transparency Initiatives:

Industry has also routinely requested to access compiled compliance actions and 483 lists of observations. The FDA has released the transparency websites in a effort to provide easy access to regulated industry trends and lists observations by program area.

FDA has also issued a summary of the most common inspectional observations of objectionable conditions or practices that are made during inspections. The implementation of a search based data portal that includes the names and addresses of inspected facilities, the date(s) of inspection, type of FDA-regulated products involved, and final inspectional classification.

The slow release of updated industry guidance for drugs, devices, and biologics should be the next focus area. Without enhanced guidance industry will continue to struggle with enhanced FDA inspections.

Possible budget cuts and user-fee money shortfalls may stifle many modernization initiatives including the transparency database up-keep. The transparency initiatives are beneficial for two reasons.

The system allows industry to understand that all the bad news is a quick click away as opposed to the slow freedom of information (FOI) request system and search enabled access. Regulated industry will now have quick access to view trend access for FDA focus areas to ensure the same mistakes are not continuously repeated globally.

This is a step in the right direction unless your business model depends on tracking and trending FDA regulated industry compliance actions for paying customers.

I hope the health care industry understands the vital resource now provided in an easy access form. The hardest part will be navigating the FDA website to find every possible resource available and pertinent to your industry program area.

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