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The law creates a requirement that the state’s Department of Consumer and Business Services publish a list of drugs with high price increases. Read More
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 pre-approved in favor of a more self-regulated rule. Read More
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. Read More
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 its decisions. Read More
Assessing impurities involves identifying those that have already been identified and those that could potentially be present in the final substance. Read More
It also argued that its product should not be a priority for alternative bioequivalence pathways because three generic versions of Efudex are already on the market. Read More
The doctor lost his medical license and position as a professor at Brown University’s medical school, and was ordered to pay over $750,000 dollars to insurance companies. Read More
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. Read More
Judicial precedent holds that companies or entities are only liable under the FCA if they were reimbursed specifically as a result of false representations, he said. Read More
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 official. Read More