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 ...
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 ...
The suit was filed by the Outsourcing Facilities Association (OFA), a trade group that represents 503B compounding pharmacies, seeking to overturn the FDA’s decision. After the suit was filed ...
Strategic outsourcing can be a bulwark for companies, helping to guard against the full effects of a challenging economy.
The Outsourcing Facilities Association, a trade group that also represents compounding pharmacies, filed a lawsuit against the FDA after the agency determined the drugs were no longer in short supply.
Lilly on Wednesday filed a motion to intervene in a lawsuit brought by compounding industry group the Outsourcing Facilities Association (OFA) and compounder FarmaKeio Custom Compounding in U.S ...
The FDA declined to comment. The Outsourcing Facilities Association, which brought the lawsuit along with a Texas compounding pharmacy did not immediately respond to requests for comment.
Danish pharmaceutical giant Novo Nordisk A/S (NYSE:NVO) submitted a Citizen Petition to the FDA requesting the exclusion of liraglutide from the 503B Bulks List, a registry of substances that ...
following a proposal by the trade group the Outsourcing Facilities Association (OFA) to add the molecule to its compounding roster. Apart from Victoza, which was approved for Type 2 diabetes in ...
In a Citizen Petition posted on Regulations.gov, Novo Nordisk (NVO) noted that the Outsourcing Facilities Association, or OFA, has nominated liraglutide be added to their list of bulk drug ...