In a boost for big pharma, the European Medicines Agency raised the fee-reduction rate for non-small and medium-sized enterprises seeking assistance on adult-only protocol from 40 percent to 75 percent, effective Jan. 1. Read More

U.S. President Barack Obama Nov. 27 signed into law a bill establishing both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary U.S. Food and Drug Administration oversight of compounding pharmacies. 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 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Drugmakers are pushing back against an Australian draft guidance on batch release protocols, asking the Therapeutic Goods Administration to allow authorized persons without access to the complete marketing application to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

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