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The U.S. Food and Drug Administration and Customs and Border Protection are accepting applications for an 18-month pilot of a “trusted trader” program. The initiative aims to reduce inspections and oversight of products imported from manufacturers that establish tough internal import control programs of their own. Read More
A trio of European pharmaceutical trade groups is seeking greater clarity around the European Medicines Agency’s initiative to streamline the drug approval process through parallel reviews for both reimbursement and safety and efficacy. Read More
The FDA has been asked to turn over a trove of information related to the development of its proposed generic drug labeling rule, with GOP leaders of a key House investigative committee claiming the agency engaged in “dubious” behaviors in the rulemaking process. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More
Two pharmaceutical industry groups are welcoming a recommendation by Irish regulators that could allow as many as 34 drugs to be sold through pharmacies without a prescription. Read More
Brand manufacturer Acorda is fending off at least six different generic challenges filed in the last few weeks to its multiple sclerosis drug Ampyra. Read More
The FDA has rejected a citizen petition filed by health advocacy group Public Citizen calling for a black-box warning about cardiovascular risks on testosterone products. Read More
German manufacturer Fresenius Kabi’s U.S. subsidiary is recalling nearly 3 million vials of an injectable anti-seizure medication due to glass flakes in sample vials. Read More