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By Kalie E. Richardson, Hyman, Phelps & McNamara | The FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program. Walk through the requirements, specifications to be prioritized, and a timeline for next steps. | |
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By Sanjeev Kumar, Denmark | Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues. | |
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By Smiriti Gupta, NIRAS | This is the second part in a series about current bioprocessing practices. Explore the latest in downstream manufacturing: separation, purification, sterile filtration, and aseptic filling. | |
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