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Drugmakers should review the marketing contracts they have in place with pharmacies or other third parties to ensure the information they send to patients complies with new HHS limitations. Read More
Prosecutors appear ready to lean more heavily on the False Claims Act in prosecuting off-label marketing cases, sidestepping a ruling in the U.S. Second Circuit that found off-label promotion was protected free speech and not prosecutable under the 1938 FD&C Act. Read More
A federal appeals court has raised the bar for whistleblowers filing False Claims Act (FCA) suits against drugmakers, saying they must provide specific information about the fraudulent claims made, not just broad allegations about a drugmaker’s conduct. Read More
Merck Dec. 9 offered to pay out $27.7 million to settle nearly 1,200 personal injury lawsuits claiming its osteoporosis drug Fosamax caused jaw-bone deterioration known as osteonecrosis of the jaw (ONJ). Read More
As more critics of the FDA’s approval of the painkiller Zohydro ER come forward, the agency says it will not limit approval of new opioid painkillers to those with abuse-deterrent properties. Read More
A group of generic drugmakers is proposing the FDA take the lead on initiating drug labeling changes prompted by adverse events, rather than relying on individual companies to initiate the changes. Read More
Beginning today, new safety and efficacy findings that emerge during postmarket clinical trials should be reported in periodic safety update reports (PSURs) submitted to the European Medicines Agency (EMA). Read More
CDER Director Janet Woodcock told lawmakers the FDA’s current medical information system is outmoded and the agency is developing the Patient Medication Information (PMI) document — a single, standardized medication information leaflet — to fix it. Read More
The European Medicines Agency is urging manufacturers of urokinase-based drugs to estimate the chances that an individual dose of a product might be contaminated with pathogens. Read More
The European Medicines Agency has launched a collaborative five-year program with the goal of developing a blueprint for a pan-European framework for monitoring the benefits and risks of vaccines throughout their lifecycles. Read More
The European Commission is threatening to take legal action against four EU member states for failing to implement the Falsified Medicines Directive, an EU-wide anticounterfeit initiative that took effect in January. Read More
Drugmakers would be required to revise product labels to reflect new health risk information, including updates on pediatric warnings, and conduct additional tests when issues arise around at-risk populations, under legislation introduced Dec. 6 by Canada’s health minister. Read More