Quality Systems

Aug 01, 2018
BioPharm International
Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.
Aug 01, 2018
BioPharm International
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Jul 27, 2018
By BioPharm International Editors
The recommended drugs include two orphan medicines and three biosimilars.
Jul 26, 2018
Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.
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
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.
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