The FDA plans to require risk evaluation and mitigation strategies for opioid analgesics — including immediate, extended-release and long-acting formulations — to ensure the benefits outweigh the risks of misuse,…
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Source: International Pharmaceutical Regulatory Monitor
The Justice Department recovered $4.7 billion in False Claims Act settlements, with the largest recoveries coming from the life sciences industry at $1.2 billion in the last fiscal year. Source:…
Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows…
Indian drug regulators in seven states have accused 18 drugmakers of selling substandard therapies after quality tests identified a range of product issues ranging from deceptive labeling to inappropriate quantities…
The European Medicines Agency published new guidance on whether less comprehensive data can be used to support a new indication for a previously approved orphan drug product. Source: International Pharmaceutical…
Drugmakers have expressed concern about the German government’s proposal to restrict drug pricing — contending that the measure penalizes research and development. Source: International Pharmaceutical Regulatory Monitor
The development process for biosimilar heparins no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency adopted a final guideline setting out the information required for the evaluation of active chemical substances used in drug products. Source: International Pharmaceutical Regulatory Monitor
The International Council for Harmonisation adopted an update to its good clinical practice guideline, recommending approaches to clinical trial design and management, as well as ensuring patient protection and data…