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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
Drugmakers are pushing back against an Australian draft guidance on batch release protocols, asking the Therapeutic Goods Administration to allow authorized persons without access to the complete marketing application to release batches of a drug. Read More
China cleared the way for the U.S. Food and Drug Administration to add 10 new drug investigators to its local roster, following a Dec. 4 meeting between U.S. Vice President Joe Biden and Chinese President Xi Jinping. Read More
Under Brazil’s new antibribery law, prosecutors will be able to charge companies for bribery based on their actions outside that country. The “Clean Company Act,” as it is commonly known, takes effect in January. Read More
The European Medicines Agency may postpone a trial transparency initiative that was scheduled to take effect Jan. 1, 2014, due to an overwhelming number of comments from stakeholders. Read More
Merck Monday 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
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
Lawmakers want the FDA to explain how hackers broke in to the CBER online submission system to steal personal user information and what the FDA has done to prevent a recurrence. Read More
The EMA said Friday it is investigating Ariad's leukemia drug Iclusig for the risk of blood clots, the same serious adverse event that prompted an FDA investigation and safety alert. Read More
The FDA has approved Auxilium Pharmaceuticals’ Xiaflex biologic injection for Peyronie’s disease, a deformity of the penis caused by a lump of plaque that results in a curvature of at least 30 degrees. Read More