Industry News

Jul 25, 2018
Commissioner Gottlieb is reorganizing FDA in the hopes of streamlining policymaking.
Jul 23, 2018
By BioPharm International Editors
The agency announced two research collaborations on bulk lists, updates to categories of bulk drug substances, and issued a warning about a bulk drug substance used in compounding.
Jul 23, 2018
Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.
Jul 19, 2018
By BioPharm International Editors
FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.
Jul 19, 2018
In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.
Jul 19, 2018
By BioPharm International Editors
Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.
Jul 19, 2018
By BioPharm International Editors
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
Jul 16, 2018
By BioPharm International Editors
Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
Jul 12, 2018
By BioPharm International Editors
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
Jul 12, 2018
By BioPharm International Editors
CPhI Korea to feature zone for finished dosage formulation drug products.
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