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Eagle Pharmaceuticals prevailed in an appeals court ruling that the FDA can grant orphan drug exclusivity to multiple drugs for the same rare disease. Read More
Trials should identify anticipated reactions and characterize suspected adverse reactions using patch or photopatch testing with the active and excipient ingredients as well as the finished product, the agency said. Read More
The FDA detailed how sponsors can support the effectiveness of investigational new drugs or new drug uses for treatment of certain rare diseases, in final guidance published Friday. Read More
Sponsors should discuss their enrollment goals with sites and investigators to achieve greater participation of elderly patients, the agency said. Read More
The FDA spelled out the conditions under which it will not take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. Read More
The Trump administration’s plan for importing drugs from Canada will not result in lower prices for Americans, according to a slew of comments from drugmakers, industry groups and the Canadian government on the FDA’s proposed rule. Read More
A federal jury in Houston, Texas found a drug compounder guilty of billing the federal government more than $20 million for unnecessary compounds. Read More