May 26, 2017

Vol. 9 No. 21

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FDA Warns Chinese API Manufacturer Over Quality Management, Record-Keeping

The FDA warned Chinese API manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Materials for inadequate quality management and record-keeping. Read More

Drugmakers Seek Clarifications of FDA’s Interchangeability Guidance

More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. Read More

Warning Letter Roundup: FDA Warns Three Firms Over GMPs, Validations

The FDA issued warnings to three device manufacturers for failures in GMPs, validations, MDRs, and other quality-related areas. Read More

CFDA Sees Increase in Adverse Event Reports

China’s Food and Drug Administration received more than 350,000 medical device adverse event reports in 2016, an increase of 10 percent on the previous year. Read More