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The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle. Read More
After the EMA issued a report on its adaptive pathway, a German agency took the agency to task for leaving stakeholders in the dark on real-world evidence use. Read More
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has effectively banned products from a Pfizer plant in India after a joint inspection by the FDA, MHRA, Australia’s Therapeutic Goods Administration and Health Canada, the first joint investigation by the four agencies. Read More
A German agency criticized a report on the EMA’s adaptive pathway, taking the agency to task for leaving stakeholders in the dark on use of real-world evidence. Read More
The FDA wants drugmakers to use clinical remission as their primary endpoint when conducting trials for short-term ulcerative colitis therapies. Read More
The FDA is simplifying the process of developing written procedures for an IRB, providing industry with a comprehensive checklist that satisfies both FDA and HHS requirements. Read More
Better communication with states is needed when the FDA stops a drug compounder from operating, the agency said in a new set of recommendations. Read More
The expanded HHS mandate that clinical trial investigators publish their full results on ClinicalTrials.gov is backed up with strong consequences for non-compliance that will be enforced by the FDA and the National Institutes of Health. Read More
The FDA is turning up the heat on pharmaceutical firms for a range of GMP violations, firing off warning letters to three companies over issues ranging from data integrity to risk management. Read More