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Indian officials are accusing FDA investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for local regulators to tag along on FDA drug manufacturing inspections as observers. Read More
With the FDA stepping up scrutiny of data integrity during facility inspections, drugmakers must be ready to answer tough questions about their electronic record system, an inspections expert said. Read More
Nothing is stopping Sandoz from launching the first U.S. biosimilar, now that a federal judge has denied Amgen’s bid for an injunction blocking the alternate version of its blockbuster chemotherapy product Neupogen. Read More
The FDA and Department of Justice are pursuing prosecutions of several international drugmakers for serious manufacturing quality violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More
Hundreds of children as young as two years old will now be able to get Vertex Pharmaceuticals’ game-changing cystic fibrosis treatment, following FDA approval Thursday. Read More
Janssen’s blockbuster Xarelto is the target of another liability lawsuit, this time by 12 plaintiffs in California federal court who claim the blood thinner caused gastrointestinal bleeding. Read More
Advocacy group Public Citizen is urging the FDA to pull oral forms of the antifungal drug ketoconazole from U.S. shelves due to serious health risks. Read More