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- AI and data sharing essential for safer cell and gene therapies, says industry leaderThe author argues that keeping data secret in cell and gene therapy harms patients, and that a commitment to transparency and artificial intelligence is needed to make these treatments safer and mo…
- FDA updates guidance to clarify ANDA and 505(b)(2) approval pathwaysThe FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways. The guidance clarifies the distinction between traditional Abbreviated New Drug Appl…