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Latest From Drug Safety
An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized.
Boehringer wants supplemental empagliflozin claim as insulin adjunct to improve glycemic control in type 1 diabetes, but US FDA questions the size of the clinical benefit and the magnitude of a diabetic ketoacidosis risk.
Agency’s approach to risk-based postmarketing safety surveillance explained in new draft document issued under the 21st Century Cures Act; product characteristics and intended use guide the frequency and extent of adverse event report screening, with newer drugs undergoing weekly reviews for three years after approval.
US FDA's focus on areas such as REMS abuse may have prompted certain brand sponsors to shift their focus to the commercial space to keep generic competition off the market, former commissioner Scott Gottlieb tells the Association for Accessible Medicines.
New Zealand is the latest regulatory body to take action over the hepatic risks of the widely used painkiller paracetamol.
The European Medicines Agency's drug safety committee has concluded that Pfizer's Xeljanz could increase the risk of blood clots in patients who are already at high risk. The committee has also recommended restrictions on the use of Sanofi's multiple sclerosis drug, Lemtrada.
A new guidance document explains how Pakistan’s revamped pharmacovigilance system will work.
US FDA’s approval of labeling supplements for the hypoactive sexual desire disorder drug followed Sprout’s appeal of a safety-related change order; boxed warning now states patients should wait at least two hours after drinking alcohol before taking flibanserin.
Agency denies citizen petition requests for boxed warning on risk of impulse control behaviors and other psychiatric disorders with the class of drugs used to treat Parkinson’s disease and restless legs syndrome, but agrees with one petitioner that some safety-related changes are warranted.
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