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The FDA is seeking a permanent injunction against a California drugmaker, saying the company manufactures and distributes over-the-counter vaginal products without proper regulatory approval. Read More
The FDA would require biosimilars to carry the same name as their reference drug counterparts under a proposal being pushed by healthcare payers and GPhA. Read More
The FDA is renewing the call for nominations for the list the agency is building of active drug substances that can be used to compound drug products, saying many of the responses to its December effort to build the list were inadequate. Read More
Over the next five years the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
A European Medicines Agency committee has clarified what kinds of drugs may be classified as advanced-therapy medicinal products (ATMPs), including the criteria for classifying cells and tissues as "engineered." Read More
International authorities recently seized more than $31 million in potentially counterfeit and dangerous drugs and shuttered over 10,600 websites for peddling unapproved and substandard pharmaceuticals, in the third annual international sweep of its kind. Read More
Sponsors of biosimilars need to demonstrate how their products compare with reference drugs, including pharmacokinetic and pharmacodynamic data to show compatibility in clinical trials, according to U.S. Food and Drug Administration draft guidance on non-brand versions of the complex therapies. Read More
The U.S. Food and Drug Administration has been quicker to approve new active substances over the last decade than both its European and Japanese counterparts, a recent study finds. Read More