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The FDA is proposing to give generic drugmakers the power to revise product labeling in response to safety issues prior to agency approval — a power that brand drugmakers already have. Read More
The FDA has handed Daiichi Sankyo an untitled letter for making claims in a brochure that two of its hypertension treatments helped lower blood pressure in patients with severe hypertension, despite a lack of substantial supportive evidence. Read More
Johnson and Johnson’s guilty plea and $2.2 billion settlement with the U.S. government to resolve off-label marketing claims for its anti-psychotic Risperdal leaves the company with more legal fights ahead of it. Read More
The FDA is requesting that certain OTC topical antiseptic drugs be repackaged with updated labeling to decrease the risk of infection resulting from their improper use. Read More
Australia’s Therapeutic Goods Administration (TGA) is offering drugmakers a more streamlined approach for reporting adverse events in an effort to reduce manual data entry and the possible double handling of information. Read More
FDA reviewers are recommending approval of Vanda’s sleep drug tasimelteon for the visually impaired, overcoming initial disagreements with the company over acceptable primary endpoints. Read More
A bill that will require drugmakers to establish a pedigree system for pharmaceuticals within one year is expected to reach President Obama’s desk this Friday. Read More