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The FDA requested comments on planned modifications to its MedWatch system that will impact existing forms used to report adverse events, including FDA 3500, 3500A and 3500B. Read More
Representatives from the pharmaceutical and hospital industries agreed the 340B drug discount program needs reforms but disagreed as to what changes are needed in testimony before a Senate committee Thursday. Read More
The rule requiring advertisers to secure prior approval before referencing serious diseases will remain in place even after the pre-approval requirement is phased out. Read More
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