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Pink Sheet: global policy and regulatory coverage
By Vibha Sharma 26 Jul 2021
New EU guidance discusses the quality documentation needed for medicines that contain a device component for their delivery or use.
Pink Sheet: global policy and regulatory coverage
26 Jul 2021
Advisory committee will discuss five types of toxicity risks with adeno-associated virus vector-based gene therapy products at a two-day meeting...
Pink Sheet: global policy and regulatory coverage
By Derrick Gingery 26 Jul 2021
OOPD’s deputy director has been named the acting head of the office responsible for orphan and rare pediatric disease designations.
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