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- FDA updates guidance to clarify ANDA and 505(b)(2) approval pathwaysThe FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways.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…
- Study highlights limits of premarket evaluation for identifying recalls of high-risk medical devicesMore than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices sugg…