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The FDA wants to kill a lawsuit that would force it to order Johnson & Johnson to release confidential documents it used to demonstrate the safety of its antipsychotic Risperdal and reconsider a citizen petition that sought stronger safety warnings for the drug. Read More
Drugmakers can now make minor changes to drug safety assurance plans without waiting for FDA approval, reducing some of the burden of managing risk evaluation and mitigation strategies. Read More
Roche adequately warned of the risks of ingesting acne drug Accutane after April 10, 2002, a New Jersey judge ruled last week, resolving lawsuits filed by people in the state who used the product since that date. Read More
Makers of branded opioid pain relievers that want to claim their drugs are resistant to abuse must, in most cases, subject their products to three forms of tests to show the FDA how effectively they prevent misuse. Read More
Mylan is recalling two injectables — a hypertension drug and cancer treatment — due to quality control issues. Both drugs were manufactured in India. Read More
Consumer and patient advocacy groups made their case March 26 for the FDA’s proposed rule to give labeling parity to generic makers, one day ahead of an FDA public hearing to again solicit comment on the plan. Read More
Consumer and patient advocacy groups made their case for the FDA’s proposed rule to give labeling parity to generic makers, one day ahead of an FDA public hearing to again solicit comment on the plan. 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