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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
The FDA awarded Janssen’s esketamine a second breakthrough designation for major depressive disorder with imminent risk of suicide, adding a second potential indication for the investigational compound. Read More
The FDA has released its annual report to Congress on statistics on delays in approval of applications related to citizen petitions and petitions for stays of agency actions for the 2015 fiscal year. Read More
The FDA has released its annual report to Congress on statistics on delays in approval of applications related to citizen petitions and petitions for stays of agency actions for the 2015 fiscal year. Read More
After the FDA tackled compliance with international standards for restricting elemental impurities in finished drugs, the EMA has issued guidance on the same topic. Read More