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A year from now, each drug product processed and moved through the U.S. supply chain could have its own unique identifier under the Drug Supply Security Act, FDA and industry officials said at a meeting Monday. Read More
The Regulatory Affairs Professionals Society has named longtime member Paul Brooks as its new executive director, effective Sept. 12. Brooks, an expert on medical device regulation, joins RAPS after a 35-year career at the British Standards Institution. Read More
The FDA will revise its recommendations for the submission of quality metrics and provide advice on comparative analyses for drug-device generics before the year ends. Read More
The U.S. Department of Justice issued grand jury subpoenas to Taro Pharmaceuticals and two of the company’s senior officials over the pricing of its generics, the drugmaker revealed in an SEC filing. Read More
A federal judge rendered Janssen’s composition patent for Remicade invalid, marking a loss for the company engaged in ongoing efforts to block biosimilar competition. Read More
Three of four generics makers prevailed in a patent infringement lawsuit by Eli Lilly as a federal judge ruled that they either did not infringe on Eli Lilly & Co.’s patents or proved them to be invalid. Read More
A judge ruled that two patents covering Vanda Pharmaceuticals’ schizophrenia drug Fanapt were valid and one was infringed on by Roxane Laboratories. Read More