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Drug Safety

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Latest From Drug Safety

Differences Put Aside As ICH Finalizes Guide On Post Approval Changes

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.

International Drug Safety

Boehringer's Empagliflozin Heads To Advisory Cmte. With Questions On Treatment Effect

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.

Advisory Committees Metabolic Disorders

Postmarketing Safety: US FDA ‘Best Practices’ Include Weekly Adverse Event Screening For New Drugs

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.

Drug Safety Biosimilars

Gottlieb: Branded Industry 'Gaming' Tactics Have Shifted From Regulatory To Commercial Space

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.

Generic Drugs Risk Management

NZ To Tighten Paracetamol Safety Warnings

New Zealand is the latest regulatory body to take action over the hepatic risks of the widely used painkiller paracetamol.

Drug Safety New Zealand

EMA Recommends Caution For Pfizer's Xeljanz

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.

Europe Drug Safety

Pakistan Steps Up Pharmacovigilance

A new guidance document explains how Pakistan’s revamped pharmacovigilance system will work.

Pakistan Drug Safety

Sprout’s Addyi Loses Blanket Alcohol Contraindication And REMS Distribution Restrictions

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.

Drug Safety Post Market Regulation & Studies

Dopamine Agonists: US FDA Orders Safety Labeling Changes But Not Boxed Warnings

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.

Drug Safety Neurology
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