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The European Medicines Agency has begun a public consultation on revised module V of the good pharmacovigilance practices on risk management systems, which clarifies what risk management plans should focus on over a product’s lifecycle. Read More
Jordanian drugmaker Hikma Pharmaceuticals will sell off two drugs and relinquish marketing rights to a third to avoid tangling with the Federal Trade Commission on its planned purchase of a Boehringer Ingelheim subsidiary. Read More
Regular price reevaluations can lower drug prices in individual European countries, but the only way to ensure significant price cuts is through EU-wide collaboration, according to a new report. Read More
Drugmakers have asked the FDA to think “globally” with the international community as they weighed in on the agency’s draft guidance on established conditions for reporting chemical, manufacturing and control changes. Read More
Lawmakers grilled FDA interim Commissioner Stephen Ostroff during a budget appropriations subcommittee hearing Thursday over the agency’s request for $5.1 billion for fiscal 2017. Read More
The Senate was urged Thursday to permanently reauthorize the Creating Hope Act, which would provide market incentives to pharmaceutical companies to develop drugs for pediatric rare diseases, ahead of a March 9 markup of the bill by the Senate HELP Committee. Read More
A year after announcing his Precision Medicine Initiative, President Barack Obama has outlined progress on the project, which aims to accelerate personalized medicine. Read More