Simplifying Global Compliance
Items Tagged with 'Guidances'
The FDA issued a guidance classifying computerized labor monitoring systems into Class II and providing recommendations to manufacturers submitting 510(k)s for these devices. Read More
New CDRH guidance supports the reclassification of herpes simplex virus (HSV) types 1 and 2 serological assays from Class III to Class II. Read More
Individual adverse events in clinical trials are not necessarily the same thing as unanticipated problems and may not have to be reported as such to the institutional review board (IRB), according to new draft guidance from the FDA. Read More
The U.S. Food and Drug Administration (FDA) issued a final guidance giving recommendations on how to design, conduct and evaluate clinical studies looking at the effects of corticosteroids on growth in children. Read More
The U.S. Food and Drug Administration (FDA) will update its current good manufacturing practices (cGMPs) quality systems (QSs) guidance to conform to international pharmaceutical QS guidelines, the agency said March 23 at a Drug Information Association conference. Read More
The European Medicines Agency (EMEA) has published a draft guideline describing scientific principles and methodology for conducting environmental risk assessments (ERAs) of gene therapy medicinal products that contain genetically modified organisms, or GMOs. Read More
Individual adverse events in clinical trials are not necessarily the same thing as unanticipated problems and may not have to be reported as such to the institutional review board (IRBs), according to new draft guidance from the FDA. Read More
The FDA is recommending that manufacturers identify in physician labeling the threshold at which increasing the dosage of a drug product provides no additional clinical benefit, according to a draft guidance released last week. Read More
CDRH will, under some circumstances, allow laser product manufacturers to use alternate means to provide the required certification, identification and warning labeling without applying for or receiving approval, according to a recent guidance. Read More
A new U.S. Food and Drug Administration (FDA) draft guidance describes how firms can ensure certain types of oxygen devices comply with Class II special controls requirements. Read More
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