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- Former NIAID adviser David Morens pleads guilty to concealing records and defrauding governmentDavid Morens, a former top National Institute of Allergy and Infectious Diseases official and longtime senior adviser to former NIAID leader Anthony Fauci, entered a guilty plea on Tuesday on charg…
- FDA updates guidance to clarify ANDA and 505(b)(2) approval pathwaysThe FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways.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…