Here's Your Chance to Weigh in on FDA Compliance Focus

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Patrick Stone, President, TradeStone QA

The FDA is evaluating every regulated program in order to enhance compliance strategy. The drug program is on deck for the enhanced program evaluations and the agency will open the comment period for the next sixty days.

The enhancement in drug regulations will mean new drugs in the pipeline will take longer to get to market and the products on the market will endure post market safety studies for continuing evaluation of safety and effectiveness.

I would recommend drug companies make it clear in their comments that these FDA changes will make life tougher for small businesses and elongate the timetable they work with in getting new products to market.

I think that the already rising cost of health care will skyrocket to new highs when the enhanced drug regulations are implemented. Some of the proposed changes appear necessary but only time will tell what regulations are actually enacted.

That’s why it’s important for industry to weigh in with comments.

Combination therapies will have to include much more safety data or risk rejection from CDER. Animal studies (GLP) will be increased for toxicity and risk benefit.

I have observed that many good laboratory firms are conglomerating and outsourcing to far east partners. But the price of doing business out of country will not be cheaper in the long run. Shipping costs and intellectual loss will have to be factored into the great globalization effort.

Quality by design (QbD) is a pilot project now but its reference in the federal registry heralds the inevitable federal mandate. The actual report for new enhanced drug regulation may be found here.

Big pharma may be able to navigate the new ocean of regulation but what happens to the start-up biotech companies? Your voice counts for the next 60 days and then the new regulation will follow accordingly.

Make sure to follow Patrick on Twitter.

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