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The FDA can exercise flexibility on the quality manufacturing information it requires drugmakers to present under expedited drug approval processes, says a final guidance. Read More
The European Medicines Agency is considering new trial designs using pathologic complete response, or pCR, as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early-stage breast cancer. Read More
Australia’s Therapeutic Goods Administration has set a September deadline for companies to adopt a common technical document format for over-the-counter drug submissions. Read More
Generic drugmakers in the U.S. and EU are calling on regulators to create uniform approval pathways for biosimilars and generic medicines, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is now accepting applications for its Early Access to Medicines Scheme, which allows drugs for life-threatening diseases to be approved on an interim basis so that patients can get them sooner. Read More
The European Medicines Agency is urging manufacturers of biosimilar insulin-containing products to demonstrate similar pharmacokinetic and pharmacodynamic profiles as the gold standard in proving efficacy similarity to their reference products. Read More
The European Medicines Agency is recommending that clinical trial sponsors evaluate local tolerance of medicinal products at contact sites on the body as part of a trial’s general toxicity studies. Read More
With generic competition on the horizon, Sanofi and Eli Lilly are collaborating to turn the popular erectile dysfunction drug Cialis into an OTC product. Read More
Drugmakers should evaluate potential names for new drugs and weed out candidates that include elements such as medical abbreviations, inactive ingredients and partial lists of active ingredients, the FDA says. Read More