Taking a drug holiday

Drug Holidays – Temporary Suspension of Therapy; Drug Labeling Consultant’s Perspective

Drug holidays are not often described in the U.S. professional labeling of prescription drug products. However, they are routinely employed across various classes of drugs as well as a variety of patient populations. As the name implies, a drug holiday is the temporary suspension of active therapy[1], and is usually enacted to avoid adverse events…

FDA Adds 67 New/Revised Product Specific Bioequivalence Guidances

“To further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.” On…