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The parents of twin girls with a rare genetic disorder sued a drugmaker and therapy accelerator for misappropriating the children’s trial data to secure a breakthrough therapy designation. Read More
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 and the Department of Defense announced a joint program Tuesday to prioritize development of medical products for deployed military personnel. 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
The FDA hit BODE Chemie with a Form 483 for failing to follow proper quality control procedures, in addition to other deficiencies at its facility in Hamburg, Germany. Read More