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CDER plans to release 93 new or revised guidances for drugmakers in 2019, spelling out the center’s current thinking on issues ranging from risk-benefit assessments for opioids to exclusivity periods for generics. Read More
As HIV patient advocates urge the federal government to “break” drug patents in an effort to lower the prices of HIV drugs, an intellectual property think tank cautioned that the tactic could backfire. Read More
A bipartisan group of senators has introduced legislation that would address one of outgoing FDA Commissioner Scott Gottlieb’s pet peeves — the “patent thickets” preventing biosimilars from getting to market. Read More
In new guidance issued Monday, the UK’s Medicines and Health products Agency (MHRA) outlined how drugmakers and clinical trial sponsors can access the new MHRA gateway for UK submissions in case of a no-deal Brexit. Read More
A proposed Centers for Medicare & Medicaid Services requirement that Medicare Part D plans place generics only on generic formulary tiers could have lowered patients’ drug costs by almost $16 billion over a three-year period, according to an analysis by healthcare consulting firm Avalere. Read More