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The FDA released a final guidance on pediatric labeling of prescription drugs that, among other recommendations, calls for black box warnings on medicines with inactive ingredients that might be dangerous to babies and children. Read More
Some Australian drugmakers are still figuring out how to pass muster during the Therapeutic Goods Administration (TGA)’s new pharmacovigilance inspections introduced in 2017, according to the TGA’s first metrics report. Read More
CDER plans to release 93 new or revised guidances for drugmakers in 2019, including more than a dozen on drug quality and chemistry, manufacturing and controls. Read More
UK lawmakers on Friday failed to approve an orderly withdrawal from the European Union, leaving drugmakers and regulators scrambling to make sense of the chaos. Read More
FDA Commissioner Scott Gottlieb and two of his top aides took to the internet Friday to urge drug sponsors to continue treatment for especially needy clinical trial patients after their studies end and before the new treatment is officially approved. Read More