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The FDA hit Tianjin-Jingye Fine Chemicals with a Form 483 for 14 violations, ranging from inappropriate re-injection and outdated stability research to lack of hand-washing facilities. Read More
A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data integrity. Read More
A European Medicines Agency committee proposed changes to clarify ambiguities in an international draft guideline for non-clinical studies of oncology drugs. Read More
The EMA’s Committee for Medicinal Products for Human Use recommended approvals for six drugs within the EU to treat a range of conditions from an endocrine disease to nausea. Read More
Sponsors would like to see clearer recommendations for non-inferiority assessments, demonstrating bioequivalence and targets for statistical analysis, before the European Medicines Agency adopts an international guideline on large clinical trials that span multiple regions. Read More
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More
The UK’s antitrust regulator alleges that Actavis and Concordia entered a pay-for-delay agreement to block the market entry of generic versions of hydrocortisone tablets and fix prices. Read More
Australia’s Therapeutic Goods Administration increased first-time inspections of drug manufacturing facilities by 16 percent in the second half of 2016, compared to the same period a year earlier, according to the agency’s latest performance report. Read More
China’s Ministry of Human Resources and Social Security has expanded the list of drugs covered by state insurance, adding more than 300 drugs to the catalog since it was last updated in 2009. Read More
The World Health Organization has released a draft update to its guidelines for API and finished drug stability testing that says it reflects how stability testing has evolved since the release of the original in 2009. Read More