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Device clinical trial sponsors will be subject to new requirements under FDA draft guidance on the format, content and review of reports related to clinical postapproval studies.
Generic drug firm Barr Pharmaceuticals is seeking FDA approval to market thalidomide, a generic version of Thalomid, a skin defect drug manufactured by Celgene, Barr announced, Dec. 26.
Instead of the new regulatory authority being proposed by lawmakers and embodied in a recent study by the Institute of Medicine, the FDA actually needs money to improve the science of regulation, according to the agency's outgoing deputy commissioner for medical and scientific affairs.
Information on GSCM Ventures’ website, including the name of a product it sells, wrongly promotes it as a treatment for obesity, an FDA warning letter said.
The process for institutional review boards (IRBs) to refer potentially high-risk clinical trials involving children to the FDA for special review is laid out in detail in a new guidance document.
In observance of the holiday season, Drug Industry Daily will not be published Friday, Dec. 22, Monday, Dec. 25, or Tuesday, Dec. 26. The next issue will be published Wednesday, Dec. 27.
The FDA warned two firms for compounding drugs that it said are “essentially copies” of commercially available, approved products without any documented reason.
Industry experts speaking at an FDA public hearing voiced their support for the agency's all-electronic submission system proposal, but warned that the agency has a lot to consider before going forward.
Common OTC pain relievers would have to carry prominent new warnings about the potential for stomach bleeding and liver damage under an FDA-proposed rule.