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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
The Chinese FDA has made sweeping reforms to the country’s nine-year-old drug registration rules, looking for industry feedback on a range of drug approval related revisions. Read More
The Bangladesh High Court has targeted 34 drug firms for ignoring an earlier ban on their products, demanding that they immediately recall their products. Read More
With strong pipelines in Europe, Japan and the U.S., regenerative medicine is poised to become a $68 billion market in the next four years, according to a new report. Read More
The UK’s drug pricing watchdog has backed the reimbursement of five therapies by NHS England, provided the companies offer the drugs at discounted prices. Read More
After nearly two years, the EMA is formalizing its iterative pathway program that saw six applications progress to formal advice from the agency. Read More