Reporting shows internal unease at the FDA about a new expedited drug program after staff described instances where usual review steps were bypassed and senior leaders were reluctant to sign off on approvals. The coverage cites concerns that reviewers were told they could skip standard reviews for at least one product and that senior signatories were hesitant to assume responsibility. The questions center on accountability and process integrity as the agency pilots mechanisms intended to speed drug access. Legal and compliance observers say clarified sign‑off authority and transparent review documentation will be required if the expedited pathway is to withstand regulatory and legal scrutiny.
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