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Former FDA compliance official offers advice to biotech startups on how to avoid CMC and GMP complete responses.
Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say
Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.
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A new barcode assessment study finds the US pharmaceutical industry has come a long way in serializing drug products over the past several years.
If the US FDA could track production, it could anticipate shortages – and national security threats from countries like China.
The EU guide covers medicines authorized at the national level and under the mutual recognition and decentralized procedures.
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