The FDA reportedly stopped issuing vouchers, though the pilot had sped some reviews; Merck's Lipfendra was already cleared, but records say its review skipped council vetting. The agency says the pilot continues, and no change to Merck's approval is reported.
Merck's named drug was cleared, and the report gives no sign of a delayed product or changed approval. Records say a council skipped vetting it, raising a process concern. The agency says the pilot continues, and career scientists now manage reviews for the remaining active drugs.
The FDA reportedly stopped issuing vouchers, but Rasonque was cleared through existing cancer-review steps. Records say the council skipped vetting it, yet the agency says the pilot continues and no change to its approval is reported.
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