A Special Protocol
Assessment is a process by which sponsors ask the FDA to assess the protocol of a proposed clinical trial to determine whether it adequately addresses scientific and regulatory requirements for the purpose identified by the sponsor.
A Special Protocol
Assessment is a binding declaration between the trial sponsor and the FDA indicating that the Phase 3 clinical study design, endpoints, and statistical analyses are acceptable to support regulatory approval of the product.
The special protocol
assessment submission is the next step in commencing a phase three programme in acute bacterial skin and skin structure infection after an end-of-phase two meeting with US Food and Drug Administration in July 2015.
Provectus is seeking consensus on a design that will qualify for Special Protocol
Assessment and supports approval of PV-10 for its melanoma indication.
Spectrum Pharmaceuticals, an international commercial stage biotechnology company, has reached an agreement with the United States Food and Drug Administration on the Special Protocol
Assessment for the Phase three clinical trial of its novel, long-acting G-CSF, SPI-2012 (eflapegrastim), it was reported yesterday.
The FDA's Special Protocol
Assessment process was implemented under the Prescription Drug User Fee Act (PDUFA) in November 1997.
It was reported on Friday that TG Therapeutics, a biopharmaceutical company, has signed a special protocol
assessment agreement with the US Food and Drug Administration.
The company said its NDA submission is based primarily on the datasets derived from its Phase 3 registration programme, which was conducted pursuant to a Special Protocol
Assessment (SPA) agreement with the FDA, and is also supported by efficacy and safety data from several additional studies, including four Phase 3 studies conducted in Japan in CKD patients on dialysis.
A registrational Phase 3 trial - the SPARC trial - for satraplatin in hormone-refractory prostate cancer (HRPC) has been initiated, following successful completion of a Special Protocol
Assessment (SPA) by the U.
Food and Drug Administration's Special Protocol
Assessment by which the drug was tested.
Provectus Pharmaceuticals Inc (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, said on Wednesday that it has received guidance from the US Food and Drug Administration (FDA) to submit its Phase 3 protocol for review, either via standard review or a request for Special Protocol
Assessment (SPA) for its PV-10 for metastatic melanoma.
Food and Drug Administration (FDA) under the FDA's Special Protocol
Assessment (SPA) process for a Phase 3 trial of 131I-TM601 in patients with newly diagnosed Glioblastoma Multiforme (GBM).