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The FDA has asked for more information on the pen injector device used in Sanofi and Zealand Pharma’s IGlarLixi combination product for diabetes, extending its review by three months. Read More
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