January is National Birth Defects Prevention Month. The 2016 theme is “Making Healthy Choices to Prevent Birth Defects—Make a Pact for Prevention.” This awareness event is sponsored by the National Birth Defects Prevention Network (NBDPN), which provides a plethora of resources to help promote awareness and prevention.
FDA Track and Trace requirements once slated to to into effect on November 1, 2015 now won’t go into effect until March 1, 2016. This is the second extension of the deadline, as the Drug Quality and Security Act (DQSA) Drug Supply Chain Act (DSCSA) was originally supposed to go into effect on July 1, […]
In October, President Obama visited Charleston West Virginia to hear local concerns about the opioid epidemic. He also announced new national efforts to combat the issue. In West Virginia, the overall drug overdose rate from 2011 to 2013 was 34 per 100,000 people, representing the highest rate in the nation. this figure includes deaths as […]
Recently, the FDA approved the use of trifluridine-tipiracil tablets as a method of treatment for patients with metastatic colorectal cancer, who’ve already been through chemotherapy. The drug was initially granted a fast-track status after a phase 3 trial showed improved survival. This drug is intended to be a third line treatment option for patients whose […]
Medline Industries, a Massachusetts-based medical and pharmaceutical device supplier, is voluntarily recalling a single lot of acetaminophen tablets. This recall applies to lot number 45810, which contains 500 mg acetaminophen tablets, but they may have been labeled to indicate 325 mg.
New Jersey Governor Chris Christie has enacted a law to ban the sale of over-the-counter cough medicine products that contain dextromethorphan (DXM) to patients under the age of 18 without a prescription. The law comes as a result of an alarming number of youth abusing the cough suppressant, which can be found in more than […]
According to the FDA, pharmacies and other facilities are no longer allowed to store sterile compounding preparations or repackaging sterile form of pseudocode in any syringes for drug administration. The practice, though common, has never been cleared or approved by the FDA.
A recombinant antihemophilic factor preparation produced by human cells has been approved by the FDA for use in patients who have hemophilia A. According to the product labeling, it is intended to provide “on-demand” treatment and control of bleeding episodes. It is also intended to help with routine bleeding prophylaxis and the management of bleeding […]
