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The GAO called on the FDA to make its plans for publishing and revising guidance for nonbiological complex drugs (NBCDs) public, noting that sudden guidance changes cause a major expense for generics developers and can delay or prevent market entry of products. Read More
The FDA will delay implementing “intended use” sections of a final rule while reassessing language that industry groups said could cause confusion. Read More
The FDA will begin publishing information from sponsor-produced clinical study reports, starting with documents volunteered by companies following a drug’s approval, as part of a broader agency effort to boost transparency in clinical trials. Read More
CellMark agreed to a consent order banning the company from any involvement in manufacturing of products that treat, cure, mitigate or prevent cancer. Read More