Regulatory Roundup: FDA Addresses the Regulation and Approval Process of PET Drugs
FDA issued last week a series of questions and answers regarding the regulation and approval process of positron emission tomography (PET) drugs. The agency published regulations on cGMP standards for PET drug manufacturers in late 2009. The Q&A guidance aims to respond to follow-up questions from the industry. Addressed are application extensions, inspections, CTD filings, the use of synthesizers, IND sponsors, trials, and more.
Columnists
Outsourcing
Commercializing Cell Therapies: Lonza’s Eytan Abraham on Challenges and Rewards
Better equipment and automated processes will be key. So, too, will the right way of approaching outsourcing relationships.
Tech Ops for Hire
As CMOs shed their old toll processing role, sponsors can expect the right questions, proactive communication, and a firm grasp of risk management and tech transfer from contract service providers.
Webcasts
- Enhancing Quality and Process Efficiency Using Continuous Manufacturing Technology for Drug Substance and Drug Product
- Safe and Cost-Effective Capsule Filling for Pre-Clinical and First-in-Man Studies
- Maximizing Roller Compaction Benefits with Proper Excipient Selection
- Developing a Comprehensive Tool Kit for Microbial Identification
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