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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
Federal right-to-try legislation passed in the Senate and now awaiting a vote in the House would only minimally benefit patient access to investigational drugs and would delay the FDA’s approval process for new drugs, according to bioethicists at the University of Pennsylvania’s Department of Medical Ethics. Read More