FDA recently requested additional information to evaluate whether a REMS is necessary for mitapivat in sickle cell diseaseFDA classified Agios’ ...
On October 20, 2026, the United States Food and Drug Administration (FDA) issued its final Regulatory Considerations for Prescription Drug ...
From now on, the ability to spot pitfalls in advance will be more effective than the ability to sell. I have lined up three ...
On October 20, 2026, the Food and Drug Administration (FDA) announced final guidance titled Regulatory Considerations for Prescription ...
GoodRx reports on 10 common issues that can delay prescription refills and offers solutions, emphasizing the importance of communication with pharmacists and prescribers.
You want to be able to make a judgement about the quality of a CBD product from its label; but how do you begin?
A mixed-methods study of 30 Spanish-preferred adults with limited English proficiency found that only 23% had received a ...
FDA finalized guidance on apps paired with prescription drugs, from inhaler trackers to dose reminders. Here is what it means ...
The US Food and Drug Administration (FDA) on Tuesday finalized guidance to address how sponsors can develop, distribute, and ...
The FDA is codifying its regulations around mobile apps that go along with prescription drugs, offering a clearer framework ...
The US FDA on Tuesday issued guidance aimed at clarifying how drug companies ​can develop, distribute and label apps used ...
FDA finalized guidance setting out how drug sponsors should label, describe and submit content from software used alongside ...