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FDA posts a draft guidance on Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Sof...[ Price : $8.95]
FDA releases a fact sheet to explain its Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program: Draft Guidance.[ Price : $8.95]
Allergan and its Forest Laboratories subsidiaries agree to pay $750 million to settle a lawsuit brought by direct purchasers of Al...[ Price : $8.95]
FDA accepts for review a Heron Therapeutics NDA resubmission for HTX-011, an investigational agent for managing postoperative pain...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Administrative Procedures for Clinical Labo...[ Price : $8.95]
FDA approves a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) for treating adult patients with community-acquire...[ Price : $8.95]
FDA authorizes NuCana to begin a Phase 3 study (nutide:121) of the investigational drug Acelarin in combination with cisplatin for...[ Price : $8.95]
Federal Register notice: FDA classifies orthopedic surgical instrumentation designed for osteochondral implants with press-fit fix...