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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 Medicines Agency has concluded a review of lax adverse event reporting at Roche, concluding the company’s failure last year to report adverse events for 19 drugs did not cause any additional risks to consumers. 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
Drugmakers are pushing back against an Australian draft guidance on batch release protocols, asking the Therapeutic Goods Administration to allow authorized persons without access to the complete marketing application to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
Still smarting from a 2012 parliamentary report lampooning India’s oversight of new drugs, the Ministry of Health is calling for accreditation of clinical trial sites and tougher regulation of clinical research. 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
Drugmakers and the FDA have different ideas about the proper scale for the agency’s quality metrics program. While industry supports collecting data on no more than four metrics, the FDA promises only that it will monitor no more than 16. 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