The Institute for Clinical and Economic Review (ICER) plans to take health equity into account in its product value assessments and has come up with some ideas for how to do that. Read More

Scientists working in the FDA’s and European Medicines Agency (EMA)’s parallel scientific advice (PSA) program kept the numbers of accepted requests from sponsors level despite needing to shift many resources to address COVID-19 related public health needs, according to a new review of the program’s productivity over the last five years. Read More

U.S. District Judge Matthew Kacsmaryk, the Texas federal judge who could outlaw the abortion pill, mifepristone, said he will render a decision on the case “as soon as possible.” Read More

The FDA clarified the agency’s interpretations of what is meant by “suspect” and “illegitimate” products in the Drug Supply Chain Security Act (DSCSA) in a final guidance released Thursday. Read More

The FDA’S Antimicrobial Drugs Advisory Committee (ADAC) voted 16 to 1 on Thursday in favor of Pfizer’s antiviral Paxlovid (nirmatrelvir and ritonavir) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Read More

The FDA dinged Dunagin Pharmaceuticals’ Rogers, Ark., drug manufacturing facility for its water system, its drug manufacturing and equipment cleaning processes, and for other deficiencies observed during an Aug. 29 to Sept. 2, 2022 inspection. Read More