FDA Drug Pricing Policy Offers Short-Term PR Gain, More Long-Term Actual Benefit
Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.
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Complex Generics May Be Part Of White House Drug Pricing Response
Document that appears to be fueling upcoming executive order includes ideas for relaxing FDA standards for complex generic approval, which may be one way of creating pressure to lower prices.
Drug Pricing 'Deeper Dive' Planned By Senate Cmte. As Industry Avoids First Blood
Hearings in July and the fall will follow, but if the first session was any indication, industry doesn't have anything to worry about.
Generic Combination Products May Be Permitted Delivery Device Variations
But US FDA officials say brand vs. generic product differences won't be appropriate in all cases and patient misuse remains a concern.