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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
FDA Commissioner Scott Gottlieb announced his resignation on Tuesday and said he will leave the agency in about a month, just under two years from his appointment in May 2017. Read More
Drugmaker and pharmacist groups called on the FDA to amend its draft guidance on supply chain verification systems, saying the draft doesn’t account for the varying conditions at facilities. Read More
FDA Commissioner Scott Gottlieb highlighted the agency’s plans to expand data collection on adverse event reporting in his Feb. 27 testimony before a key House appropriations subcommittee. Read More
Petitions aimed at delaying approvals of competing drugs are diverting resources away from the agency’s public health efforts, the FDA said in a report to Congress. Read More