by Katie Oakley | Feb 13, 2015
Since the release of FDA’s “fair balance” doctrine, which requires drug companies to split the length of a TV commercial equally between benefits and risks, many have questioned whether this policy is hurting or helping consumers. In a recent notice FDA explains,...
by Katie Oakley | Feb 9, 2015
To kick off 2015, FDA has revealed a new database of guidance documents issued by the agency. An improvement on FDA’s prior organization system, the new database provides an up-to-date, user friendly, unified list of many guidance documents issued by all offices and...
by Katie Oakley | Feb 8, 2015
While mobile health apps and wearable devices have become exponentially more popular, FDA has explained they will not be regulating “low risk” general wellness devices. Traditionally, medical devices are required to obtain FDA approval or provide evidence of...
by Katie Oakley | Jan 26, 2015
FDA has kept a close eye on psychoactive drugs—especially sleep aids—with concerns that many patients have experienced side effects well after the drug should have worn off, ultimately impairing their ability to safely perform activities such as driving, and causing...
by Katie Oakley | Dec 8, 2014
According to a recent announcement, FDA will require large compounding pharmacies to register annually, pay a $15,000 annual fee, and report a list of all manufactured products every six months. These requirements were established in three guidance documents,...
