Regulatory/GMP Compliance

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.
Jul 01, 2018
BioPharm International
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
Jul 01, 2018
BioPharm International
FDA seeks more efficient testing to spur development of less costly biotech therapies.
Jun 27, 2018
By BioPharm International Editors
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.
Jun 22, 2018
By BioPharm International Editors
FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.
Jun 22, 2018
By BioPharm International Editors
The agency launched a secure online portal for orphan drug designation applications.
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