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The FDA has issued a new guidance designed to help drugmakers identify compounds that could harm the immune system and provide direction on testing for such immunotoxicity.
Criticism from a variety of stakeholders has led the FDA to withdraw its direct final rule exempting most investigational drugs from complying with current Good Manufacturing Practices (cGMP).
An international effort between the U.S., the European Union and Japan to standardize industry submission and agency review of genomic data will move personalized medicine forward without increasing regulatory burdens, a high-ranking FDA official says.
The FDA May 1 issued guidance on updated labeling requirements for single-use devices to comply with the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which was amended in 2005.
The FDA April 25 issued guidance for industry and FDA staff on device postmarket surveillance (PS), which consolidates three separate documents into a single, comprehensive document.
How the FDA defines a hospital for the purpose of its rule requiring bar codes on drug labels is a key question affecting health care providers and drug manufacturers’ ability to comply with the rule, a hospital official says.
The FDA’s Center for Drug Evaluation and Research (CDER) has released a draft technical document on how to use structured product labeling (SPL) Release 2, which incorporates changes in the requirements for the content and format of labeling for human prescription drug and biological products.