Huge New Opportunity in Generic Drug Development Created by US FDA

The US market is to gain access to previously unavailable therapeutically equivalent generic drug formulations due to a number of changes.

Patients, prescribers, pharmacists and generic manufacturers all stand to gain from these initiatives.

On 21 June, new FDA commissioner Scott Gottlieb announced (in FDA Voice) said: "Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines."

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