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President Trump announced Wednesday that he is invoking the Defense Production Act in response to the growing coronavirus pandemic, enabling the federal government to order private industry to manufacture emergency medical supplies. Read More
Drug industry trade groups PhRMA and BIO expressed a strong distaste for the Trump administration’s strategy for tackling high drug prices by importing Canadian medicines, arguing that the plan would fail to lower costs and could put patients at risk. Read More
The FDA published a final guidance over the weekend on compounding alcohol-based hand sanitizers and said the agency will not take regulatory action against outsourcing facilities for regulatory violations for such products provided they include certain ingredients. Read More
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