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Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Read More
An FDA inspection of Isometric Pharmacy’s Salt Lake City facility revealed several GMP violations that rendered its drugs adulterated and resulted in a warning letter. Read More
Small businesses sponsoring approved generics can expect a 90 percent discount on annual user fees, offering them some relief when GDUFA II takes effect in fiscal 2018. Read More
Sen. Charles Grassley (R-Iowa) put pressure on the Centers for Medicare and Medicaid Service to release records on Mylan’s classification of the epinephrine auto-injector the EpiPen for Medicaid. Read More
Dozens of healthcare organizations, including several drugmakers and payers, wrote an open letter to President Donald Trump, urging him and Congress to continue the pursuit of value-based care. Read More
Several large drugmakers and industry groups commented on FDA’s proposal to require higher quality management standards for nonclinical studies used to support product applications. Read More