FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly ...

The FDA initially declared the tirzepatide shortage over in October, but the Outsourcing Facilities Association, a trade group for compounding pharmacists, sued, claiming the drug was still in ...

Ivim Health raises concern over US FDA’s arbitrary critical deadline comes; submits Amicus brief to fighting patient access to GLP-1 medications: Columbus, Ohio Thursday, Februa ...

For its part, the Outsourcing Facilities Association said in a report to the court that "Survey data from this month shows increasing numbers of patients unable to obtain branded GLP-1 agonist ...

In an Amicus Brief submitted today in Outsourcing Facilities Association v. FDA in the U.S. District Court for the Northern District of Texas, Ivim Health raises urgent concerns over the FDA's ...

The company highlights that existing FDA-approved formulations lack attributes that would necessitate compounding, while the Outsourcing Facilities Association’s (OFA) nomination relies on ...

The right outsourcing partner can create access to resources like production facilities, heavy machinery, IT and more without the long-term commitment. Rather than shouldering the burden of fixed ...