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  4. RFD Jurisdictional Decisions
  5. Capsular Decisions - Products Assigned to CDER
  1. RFD Jurisdictional Decisions

Capsular Decisions - Products Assigned to CDER

A. Drugs

  • Ultrasound contrast agent
  • Dye mouthrinse to examine oral tissue
  • Orally administered drug for ultrasound imaging
  • Drug used to determine plasma volume
  • Inhaled chemoirritant to elicit cough reflex
  • Hormone for the treatment of gastrointestinal disease
  • Vital dye for ophthalmic use
  • Aerosolized polysaccharide for pulmonary disorder
  • Diagnostic drug administered to the bladder
  • Drug for in vitro treatment of sperm
  • Synthetic protein to treat HIV
  • Solution used in continuous renal replacement therapy procedures
  • Vitreous liquefaction agent
  • Oxygen-carrying liquid drug to treat pulmonary conditions
  • Antibiotic cream to treat nasal infections
  • Agent to decontaminate chemical and biological warfare agents
  • Extended-release synthetic compound for orthopedic use
  • Isotope-based drug combination to diagnose digestive disease
  • Topical agent for wound healing
  • Recombinant hormone for the treatment of obesity
  • Synthetic protein to treat chemotherapy side effect
  • Hydroxyapatite-based dentifrice
  • Solution for use in cardioplegia and preservation of the heart during cardiac surgery
  • Enzyme to degrade viscoelastic agent during cataract surgery
  • Synthetic immunomodulator for neurological use
  • Drug used in therapeutic ultrasound procedures
  • Polysaccharide for prevention/treatment of bacterial overgrowth
  • Heat-activated chemotherapy drug

B. Biological Products

  • Botulinum toxin for treatment of neuromuscular disorders
  • Recombinant protein for dental use
  • Monoclonal antibodies for treatment of blood disorder

C. Combination Products with Drug Primary Mode of Action

  • Cytotoxic agent and biological product for targeted cancer treatment
  • Gynecologic drug and delivery device
  • Photosensitizing drug and light source for cancer treatment
  • Drug and transdermal iontophoretic delivery system
  • Fluoride-containing dental device for anticaries treatment
  • Fluoride varnish for anticaries treatment
  • Drug with injector to treat erectile dysfunction
  • Drug with injector to treat anaphylactic reactions
  • Drug with implantable delivery device
  • Antiseptic skin preparation swabs
  • Peritoneal dialysis solution and administration set
  • Drug and delivery device for diagnosis of coronary artery disease
  • Drug and delivery system for cancer treatment
  • Drug and radiation emitting device to treat cancer
  • Drug and delivery system for use with vein grafts
  • Antimicrobial barrier
  • Spermicidal gel with delivery device
  • Antibiotic with biodegradable delivery device
  • Drug reconstitution and delivery system
  • Contrast agent and saline flush syringes
  • Chemoablation drug and delivery device
  • Cytotoxic agent and enzyme for cancer treatment
  • Drug and drainage device for glaucoma treatment
  • Drug and delivery system for localized bladder treatment
  • Drug and device for ex vivo photodynamic cancer treatment
  • Hormone to induce expression of breast fluids and sample collection device
  • Enzymatic debriding agent/dressing for wound management
  • Insulin and inhaler to treat diabetes
  • Synthetic drug with controlled-delivery device for ophthalmic use
  • Chemical agent and delivery system for gallstone dissolution
  • Chlorhexidine gluconate swabs
  • Radiolabeled contrast agent, production device and administration set
  • Aerosolized radiolabeled contrast agent and production device
  • Radiopharmaceutical and carrier for orthopedic use
  • Drug and delivery system for internal tissue
  • Photopheresis system and drug to treat skin cancer
  • Drug, antibody and enzyme for cancer treatment
  • PET drug and probe for tumor localization
  • Topical drug and light source to treat skin cancer
  • Patient-controlled transdermal system for pain management
  • Drug and light source for dental use
  • Drug and collagen combination for pain relief after lumbar surgery
  • Aerosolized sodium chloride for halotherapy
  • Prefilled insulin cartridges for use with a dedicated infusion pump
  • Drug-eluting device to prevent restenosis of vascular grafts
  • Condom with drug-containing gel to help maintain erection
  • Cytotoxic agent-monoclonal antibody conjugate for cancer treatment
  • Cartridges with prefilled syringes for use in specified reusable autoinjector

D. Combination Products with Biological Product Primary Mode of Action

  • Cytotoxic monoclonal antibodies with device to remove excess antibodies from patient
  • Bone morphogenetic proteins and collagenous matrices for bone regeneration
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