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The FDA is issuing new guidance on investigating out-of-specification (OOS) results that fall outside the acceptance criteria established in drug applications, drug master files, official compendia or by the manufacturer in an effort to help pharma manufacturers evaluate test results.
In an effort to help pharma manufacturers evaluate test results, the FDA is issuing a new guidance on investigating out-of-specification (OOS) results that fall outside the acceptance criteria established in drug applications, drug master files, official compendia or by the manufacturer.
The Center for Drug Evaluation and Research's (CDER) recent move to withdraw three old electronic submission guidances is just another important step in the agency's avowed policy of advancing the electronic common technical document (eCTD) format, says Nancy Smerkanich, vice president of regulatory affairs at Octagon.
The FDA released a draft guidance Sept. 28, offering advice to manufacturers of cell-based viral vaccines on the selection, characterization and qualification of cell substrates and viral seeds used to make these products.
The FDA is updating its current drug and biologics application guidance to discuss the evolving science of drug-to-drug interactions and changes to labeling requirements.
The FDA issued the final version of its comprehensive current good manufacturing practice (cGMP) guidance Sept. 29, making “no substantive changes” from the draft released two years ago, the agency said.
The FDA has issued a new guidance to help makers of cell-based viral vaccines improve the development and availability of vaccines, including those to address emerging and pandemic threats.
The FDA issued the final version of its comprehensive current good manufacturing practice (cGMP) guidance Sept. 29, making "no substantive changes" from the draft released two years ago, the agency said.
The FDA issued two draft guidances Sept. 7 on medical testing: one covering a new type of medical test called in vitro diagnostic multivariate index assays (IVDMIAs), and the other clarifying the rules for commercially distributed active ingredients of medical tests, called analyte specific reagents (ASRs).