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Meeting the demands of electronic record assurance is becoming more important for FDA-regulated life sciences companies, InfoStrength President Rita Geiger told PIR last week.
Any effective electronic signature solution should meet 21 CFR Part 11 and other regulatory compliance requirements, be easy to use and include graphical signature supports, said a new white paper from Arx.
The FDA will hold a Dec. 11 public meeting to discuss its proposed electronic identification system for drugs and other changes to the National Drug Code (NDC) Directory.
The drug, biologics and device industries could face billions in additional costs if the FDA requires risk analysis to be part of electronic recordkeeping regulations, an industry consultant says.
The FDA is working with the Nano Science and Technology Institute (NSTI) to address concerns about potential health and environmental risks from nanotechnology at a summit scheduled for 2007.
Faced with a growing threat to the $5 billion-per-year drug-eluting stent market, device manufacturers launched an information counteroffensive at a prestigious medical conference last week.
The FDA is working with the Nano Science and Technology Institute (NSTI) to address concerns about potential health and environmental risks from nanotechnology at a summit scheduled for 2007.
Until more information is known about the exact health risks presented by nanotechnology, the federal government needs to use a sliding scale to determine potential harm, a former federal official says.
The SAFE-BioPharma Association, the nonprofit that created and manages the Signatures and Authentication for Everyone (SAFE) digital identity and signature standard for the pharmaceutical and healthcare industries, will hold a two-day workshop in Chantilly, Va., beginning Nov. 8.