Category Archives: Generic Drugs

FDA and The Scarlet Letter

FDA apparently intends to implement today an idea that has been kicking around for a while to begin publishing the names of companies that have had letters of complaint lodged against them asserting that they are taking actions to block … Continue reading

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FDA’s Generic Drugs – FDA Tracker Status Update

 A month ago I was able to sit down with FDA's Deputy Commissioner Dr. Joshua Sharfstein to discuss the FDA's new effort at transparency and accountability called FDA Tracker, resulting in a podcast on the subject.  FDA Tracker is a … Continue reading

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FTC Report on Generic Drug Deals

No doubt the latest report from the Federal Trade Commission (FTC) Bureau of Competition is going to set the hair of several congresspeople on fire and will perhaps result in a hearing on the matter.  The subject of the report … Continue reading

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The Critical Path of the Critical Path

Yesterday the FDA issued a news release that was entitled the "Critical Path Opportunities for Generic Drugs" that raises more than a few interesting points. First, it has been a long time since we’ve heard much about the FDA’s Critical … Continue reading

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Global Warming for Generics

Lately the environment for generic drugs has grown much warmer. Consider, last week the FDA/CDER proposed a speedier process for considering approval of generics. Walmart, one of the biggest retail chains in the country, announced it would sell many generics … Continue reading

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