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Industry groups want the FDA to clarify its rules around manufacturer promotion of off-label drug use and are using the lawsuit to press their case. Read More
Drugmakers and patients can now access risk evaluation and mitigation strategies for FDA-approved drugs, thanks to an updated website launched by the FDA on Wednesday. Read More
The FDA expects to boost its China office staff to 35 within the next two years and its India staff to 23 as the agency focuses on increasing inspections in both countries. Read More
The Office of Pharmaceutical Quality’s “One Quality Voice” is “well on its way to becoming a reality,” CDER Director Janet Woodcock said Tuesday. Read More
Hoping to speed development of new treatments for children, the European Medicines Agency is offering drugmakers free meetings with members of its Paediatric Committee. Read More
The FDA is concerned that it takes too long to update the list of drugs withdrawn or removed due to safety or efficacy reasons and no longer acceptable for compounding, and is asking stakeholders to suggest alternatives to the advisory committee/rulemaking process. Read More