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The first U.S. clinical trial for a coronavirus vaccine got under way yesterday — a phase 1 trial of Moderna’s mRNA-1273 in collaboration with the National Institutes of Health. Read More
The FDA hit Blaine Labs with a lengthy Form 483 for a host of violations at its Santa Fe Springs, CA, facility, including repeated quality unit failures. 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
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