Australia’s Therapeutic Goods Administration will impose heavier sanctions for violations of its regulations on drug advertising, but the agency also will phase out its requirement that certain drug advertisements be…
The U.K.’s Medicines and Healthcare products Regulatory Agency released new guidance on its approach to GXP data integrity and its expectations for achieving compliance. Source: Drug Industry Daily
A federal judge ruled a proposed class action accusing Walgreens of overcharging for generic drugs must go forward. Source: Drug Industry Daily
A bipartisan bill introduced in the Senate would widen the Drug Enforcement Administration’s discretion in setting opioid production quotas, allowing the DEA to factor abuse rates and overdose deaths into…
The House of Representatives failed to pass the latest iteration of federal right-to-try legislation Tuesday night. Source: Drug Industry Daily
Pay-for-delay deals between branded and generic drugmakers in the European Union continued to decline in 2016, according to the latest update from the European Commission. Source: Drug Industry Daily
The President’s Cancer Panel highlighted the sharp increase in U.S. cancer drug prices in a 70-page report to President Trump, calling for more value-based pricing, more competition in the drug…
Potential or actual impurities in drugs should be studied for their mutagenic properties, according to a revision to an ICH guideline addendum on mutagenic carcinogens, now adopted by the FDA.…
The FDA announced plans for additional research into the impact of drug promotion on consumers’ understanding of prescription drug risks and benefits, and said a more targeted presentation of risks…
As part of its multi-pronged campaign against the opioid epidemic, the Justice Department will continue its crackdown on opioid overprescribing through False Claims Act enforcement, according to a senior DOJ…