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The FDA has revised its 2016 draft guidance on charging patients for drugs under investigational new drug applications (IND) in clinical trials or expanded access programs. The updates, which pertain mostly to expanded access, include additional recommendations on distributing first year costs and submitting statements from independent accountants. Read More
The FDA’s accelerated approval program has come under fire again, this time from a group of researchers that found only 38.9 percent of new drugs green-lighted via accelerated approval demonstrated high therapeutic value when compared with existing therapies. Read More
Colorado has chosen three supply chain partners to help the state import lower-cost medications from Canada, in anticipation of getting the FDA’s approval to launch the program. Read More
The number of drug units impacted by recalls in the second quarter of 2022 was slashed by more than half — from 435.3 million units recalled in Q1 to 20.6 million — in Q2, the lowest number of units in the past five quarters, according to Sedgwick, a company that specializes in product recalls and remediation. Read More
A federal court judge in Delaware has ruled in favor of Exela Pharma Sciences on all counts in a patent dispute over Eton Pharmaceuticals’s abbreviated new drug application (ANDA) to produce a generic version of Exela’s product Elcys. Read More
The FDA issued a warning letter to Verde Cosmetics of Northridge, Calif., for failing to conduct microbiological testing of its topical drugs and lacking adequate cleaning procedures. Read More