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Nicox, an international ophthalmic R&D company, announced it received a complete response letter related to its NDA for its cetirizine eye drop formulation AC-170. Read More
Sen. Charles Grassley (R-Iowa) wants the Department of Justice to provide details on a settlement Mylan reached to resolve claims that the company misclassified its epinephrine auto-injector EpiPen for the Medicaid Drug Rebate program. Read More
The FDA has determined that the results of the Xarelto clinical trial were not affected by a faulty monitoring device used in the trial, and that the drug’s approval will stand. Read More
Accessing a company’s policy on expanded access might be easier said than done, as most companies fail to post this information on their websites, a recent analysis found. Read More
Before the end of the year, the FDA will begin requiring that study data for NDA, BLA, and ANDA submissions be submitted to the agency in a standardized electronic data format. Read More
The Office of Generic Drugs topped last year’s approval and rejection rates, issuing 835 tentative or full approvals and 1,725 complete response letters in fiscal 2016. Read More