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CDER Director Janet Woodcock said Nov. 15 that she supports the creation of a swift-approval pathway for antibiotics that target limited patient populations. 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
Indian authorities want clinical trial sites accredited and more heavily regulated. In a new report, a panel of advisors to the Ministry of Health and Family Welfare spells out specific reforms aimed at addressing past weaknesses in the country’s clinical investigation and drug approval processes. Read More
The European Commission has approved Roche’s Kadcyla to treat patients with HER2-positive locally advanced or metastatic breast cancer previously treated with Herceptin and/or a taxane. Read More
The wrangling over trial design guidance for gene/cell therapies will extend into next year as the FDA tries to satisfy industry concerns about how elements of the trials can be standardized. Read More
Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. Read More
The European Commission has granted marketing approval for Bayer and Algeta's Xofigo to treat castration-resistant prostate cancer (CRPC) that has spread to bones but not other organs. Read More
In the wake of record-breaking numbers of drug shortages, particularly generic injectables, the European Federation of Pharmaceutical Industries and Associations (EFPIA) is advising drugmakers to establish a drug shortage task force. Read More
The European Medicines Agency (EMA) has provided generic drugmakers its first roadmap to meeting standardized EU bioequivalence requirements. Read More
The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics. Read More
For the first time brand and generic drugmakers are required to notify the EMA and individual country regulators when they withdraw a drug from the market anywhere in the EU, and the reasons why, to comply with the EU’s newly amended pharmacovigilance law. Read More
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More