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If an EU nation finds a safety issue with a drug and flags it for review, that decision will start a 60-day clock during which a drugmaker will have the opportunity to resolve all concerns about the product or face revocation or modifications to its market authorization. Read More
Amag Pharmaceuticals’ regulatory woes deepened Wednesday as its bid to seek a new indication for its flagship iron deficiency drug Feraheme was rejected by FDA reviewers. Read More
The FDA’s proposal to establish tighter controls on hydrocodone combination drug products such as Vicodin should only apply to doses 5 mg or higher, drugmakers say. Read More
Drugmakers can now submit adverse event reports to the Therapeutic Goods Administration via email using the international E2B standard alone — a move aimed at reducing manual data entry and duplicate handling of information. Read More
An advisory panel to India’s Central Drugs Standard Control Organization is calling for guidelines on the verification of fixed-dose combination drug products that are currently being sold without marketing authorization. Read More
Drugmakers that market products in Brazil have two years to present Anvisa with a full report of traceability of at least three batches, according to a resolution published in the Dec. 11 Official Journal. Read More
The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Tuesday, and the agency will soon begin withdrawing approvals for products made by companies defying the ban. Read More
Just months after launching its new cholesterol combo drug Liptruzet, Merck is recalling all of the drug that hasn’t already reached customers because of concerns that defective packaging could decrease its potency. Read More
The FDA and the World Health Organization (WHO) are considering placing new restrictions on 26 popular painkillers, including the widely used generic opioids tramadol and tapentadol. Read More
Government prosecutors are asking Aegerion Pharmaceuticals to hand over documents tied to sales and marketing of its cholesterol drug Juxtapid, putting the company in the spotlight for compliance concerns for a second time. Read More