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The Federal Trade Commission endorsed FDA draft guidance that aims to deter drugmakers from gaming the citizen petition process to delay generics. Read More
Senators Ron Wyden (D-Ore.) and Chuck Grassley (R-Iowa) introduced a bipartisan bill Tuesday that would strengthen Medicaid’s capacity to go after drugmakers suspected of misclassifying branded drugs as generics. Read More
Leading drug companies called for tweaks in the FDA’s draft guidance on postapproval changes for drugs to help clarify info and better align with ICH guidelines. Read More
The FDA is “making the process for copying these medicines more efficient and creating an easier path for generic alternatives to enter the market,” said Commissioner Scott Gottlieb. Read More
The discovery process for a revived whistleblower suit against Gilead would be more trouble than it’s worth, the Justice Department said in a brief to the Supreme Court last week. Read More
The FDA granted a petition to add warning labels for hypnotic drugs on the risk of injury from falling, but shot down calls for tougher risk assessments by drug sponsors. Read More