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Highlighting a growing dispute in the pharmaceutical industry, Johnson & Johnson is arguing that biosimilars should have international non-proprietary names (INN) that are similar to, but distinguishable from, reference products. Read More
When President Obama signed the Drug Quality and Security Act into law in November, it immediately preempted all state measures for track and trace and established one federal system for pharmaceuticals. Read More
With the new pharmaceutical track-and-trace law’s deadline for lot-level pedigrees looming, the FDA is still unclear about how it will regulate the complex requirement. Read More
The FDA may refine its planned quality metrics program to include rankings of individual drugmaker quality — at the request of industry — that will show how a company’s quality system stacks up against its peers. Read More
A new analysis of opioid availability in 104 countries suggests regulators in emerging markets increasingly important to industry are hindering sales of opioid painkillers to cancer patients. Read More
A newly introduced House bill would legalize the personal importation of prescription drugs nationally, following a Maine law enacted in 2013 that is currently facing a legal challenge brought by the pharmaceutical industry. Read More
The FDA and the World Health Organization (WHO) are considering placing new restrictions on 26 popular painkillers, including the widely used tramadol and tapentadol. Read More
A group of generic drugmakers is proposing the FDA take the lead on initiating drug labeling changes prompted by adverse events, rather than relying on individual companies to initiate the changes. Read More
Hot on the heels of Amgen’s state-level campaign to limit dispensation of biosimilars, the biotech is voicing strong opposition to plans by the FDA to allow biosimilars to share the same international non-proprietary name (INN) as the biologic they reference, calling for unique INNs. Read More
With the FDA set to tackle a host of new responsibilities, Congress should boost the agency’s fiscal 2014 funding to help it carry out its expanded mission, advocates for the FDA say. Read More
The FDA plans to mandate that manufacturers of antibacterial soaps and body washes submit clinical outcome study data that address safety and efficacy of their products, regulating them as they would other OTC medications. Read More
The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More