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The FDA expects manufacturers of genetically engineered products that could be harmful if released into the wild to submit environmental assessments (EAs) along with their biologics applications. Read More
The FDA late Friday approved Cubist Pharmaceuticals’ antibiotic Sivextro, the second drug approved for acute bacterial skin and skin structure infections as part of the agency’s effort to encourage the development of new antibiotics as a bulwark against growing drug resistance. Read More
SAN DIEGO — Two years after it was launched, the FDA’s breakthrough therapy designation, and what qualifies as a breakthrough, continues to baffle drugmakers who have experienced a roughly 63 percent rejection rate in receiving the expedited designation. Read More
Sponsors of clinical trials in the European Economic Area must begin posting summary results on the EudraCT clinical trials database starting July 21, another move in Europe’s shift toward greater clinical trial transparency. Read More
SAN DIEGO — The FDA is racing to beat a fall deadline to release a string of new guidances for generics makers that it hopes will head off a potential torrent of rejected submissions. Read More
Manufacturer Hospira’s 2005 withdrawal of its leucovorin injection was not done for effectiveness or safety reasons, the FDA said, paving the way for new ANDAs on the generic anemia drug. Read More
The FDA for the first time has consolidated all elements that generic manufacturers must include in their ANDAs in an effort to increase the success rate of new submissions. Read More
Drugmakers operating in the EU must submit additional information to the European Medicines Agency on their authorized products starting immediately, and update previously submitted information by year’s end. Read More
Drugmakers hoping to market generic and biosimilar products quickly in Brazil should pair up with the branded firms to facilitate the application process, according to an updated rule that aims to speed generic approvals. Read More
Drugmakers submitting regulatory filings in the U.S., Europe and Japan generally may use pharmacopeia texts on dosage units interchangeably in the three regions, according to a final FDA guidance that adopts guidelines from the International Conference on Harmonization. Read More