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July 02, 2018
EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Pharmaceutical Technology spoke with Sharon Ayd, executive vice-president of Pre-approval Pharmaceuticals and chief scientific officer at Regulatory Compliance Associates, about developing a corrective action and preventive action (CAPA) plan.
Maintaining good quality control practices throughout the entire manufacturing process requires robust development, a drive toward product and process understanding, and pre-established, comprehensive written procedures that are consistently reviewed and updated.
Vendors are offering template-based models and direct data-filing services to help smaller companies meet imminent deadlines.
June 27, 2018
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.
June 22, 2018
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
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.
June 21, 2018
The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.
June 08, 2018
Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.