Regulatory/GMP Compliance

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.
Jul 02, 2018
BioPharm International
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Jul 02, 2018
Legislators look to widen access to medications for addiction treatment and overdose emergencies.
Jul 02, 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 01, 2018
BioPharm International
BioPharm International asked an FDA spokesperson how the agency plans on handling these issues in the future.
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