With experience on more than 40 NDAs, EMB associates streamline the process, effectively represent your results, and support your presentations to the FDA.
angina
anti-platelet therapy for prevention
of cardiovascular disease
atrial fibrillation
cardiac failure
cardiovascular health
coronary artery bypass graft surgery
coronary artery disease
deep vein thrombosis
dyslipidemia
heart failure
hypertension
intermittent claudication
ischemia
myocardial infarction
pacemakers
stents
thrombolytic therapy
venous thrombophlebitis
acne
acute bacterial skin and skin structure infection
aesthetic medicine
artificial skin
atopic dermatits
excessive sweating
patient preoperative skin preparation
psoriasis
urticaria/hives
diabetes
diabetic macular oedema
diabetic neuropathy
growth hormone deficiency
hormone replacement therapy
(hypogonadal males, menopausal females)
hyperglycemia
hyperthyroidism
hypoactive sexual desire disorder
hypoglycemia
obesity
vasopressor-dependent septic shock
anal fissures
constipation
Crohn's disease
diarrhea
duodenal ulcer
emesis (chemotherapy-induced, postoperative,
radiotherapy-induced)
gastroesophageal reflux disease
heartburn
hemorrhoids
irritable bowel syndrome
motion-induced nausea and vomiting
oral mucositis pain relief
in patients receiving stem cell transplants
ulcerative colitis
central precocious puberty
hereditary inclusion body myopathies
Pompe's disease
Prader-Willi syndrome
postmenopausal vasomotor symptoms
vaginal atrophy
anemia
chronic liver disease-related thrombocytopenia
hemolytic paroxysmal nocturnal hemoglobinuria
hemophilia A
hyperkalemia
idiopathic thrombocytopenia purpura
severe aplastic anemia
thrombocytopenia
acute bacterial skin and skin structure infection
acute exacerbation of chronic bronchitis
acute otitis externa
allergic rhinoconjunctivitis
acute otitis media
bacterial vaginosis
community-acquired pneumonia
gram-positive pathogens
hepatitis (B, C)
human immunodeficiency virus
(acquired immunodeficiency syndrome,
Type 1, wasting syndrome)
human papillomavirus
Mycobacterim avium complex
perennial allergic rhinitis
pharyngitis
rapid screening tests
respiratory syncytial virus
seasonal allergic rhinitis
sepsis
sinusitis
soft tissue infection
tonsillitis
tuberculosis
uncomplicated urinary tract infections
vaccine
Vancomycin-resistant Enterococcus faecium
ventilated nosocomial pneumonia
vulvovaginal candidiasis
bone regeneration in foot/ankle fusions
Dupuytren's contracture
fracture healing
gout
lateral epicondylitis (tennis elbow)
osteoporosis (male, postmenopausal women,
glucocorticoid-induced)
pain (back, knee replacement)
rotator cuff repair
spinal cord injury
AV fistula (renal failure dialysis patients)
AV grafts (renal failure dialysis patients)
erectile dysfunction
pain (pelvic of bladder origin)
Peyronie's disease
uncomplicated urinary tract infections
urinary incontinence
Alzheimer's disease
amyotrophic lateral sclerosis
attention deficit hyperactivity disorder
cognition
epilepsy (pediatric, adult, childhood absence)
hemiplegic migraine
internuclear ophthalmoplegia
(multiple sclerosis patients)
lewy body dementia
migraine
multiple sclerosis
pain (associated with chemotherapy, back,
cancer breakthrough, dental, inflammatory,
knee replacement, neuropathic, pelvic of
bladder origin, postoperative)
Parkinson's disease
restless leg syndrome
seasonal affective disorder
stroke
wrist, hand, ankle and/or foot spasticity
calcium supplement
dietary supplement
vitamin D insufficiency in cystic fibrosis patients
adenocarcinoma
advanced or metastatic solid tumors
brain cancer
breast cancer
breast cancer risk reduction
cancer deep vein thrombosis
cancer of unknown primary
colon cancer
colorectal cancer
emesis (chemotherapy-induced,
radiotherapy-induced)
endometrial cancer
esophageal cancer
fallopian tube cancer
follicular B-cell lymphoma
gastrointestinal cancer
graft-versus-host disease
hepatocellular carcinoma
immunotherapy
leukemia (acute lymphoblastic, acute myeloid,
chronic lymphocytic)
liver cancer
lung cancer
lymphoma (lymphoblastic)
melanoma
melanoma metastatic to liver
mesothelioma
metastatic breast cancer
metastatic pancreatic adenocarcinoma
multiple myeloma
myelodysplastic syndrome
myeloma
non-small cell lung cancer
oral mucositis pain relief in patients
receiving stem cell transplants
ovarian cancer
pain (cancer breakthrough,
associated with chemotherapy)
pancreatic cancer
peritoneal cancer
prostate cancer
refractory solid tumors
renal cell cancer
skeletal-related events due to bone metasteses
skin cancer
small cell lung cancer
solid tumor malignancies
squamous cell carcinoma of the head and neck
unresectable hepatocellular carcinoma
urothelial carcinoma
contact lens disinfection
diabetic macular oedema
glaucoma
internuclear ophthalmoplegia
(multiple sclerosis patients)
macular degeneration
acute otitis externa
acute otitis media
allergic rhinoconjunctivitis
Meniere's disease
perennial allergic rhinitis
pharyngitis
seasonal allergic rhinitis
sinusitis
temporary threshold shift
(temporary noise-induced hearing loss)
tonsillitis
bipolar disorder
depression
generalized anxiety disorder
multiple depressive disorder
opiate detoxification
schizophrenia
smoking cessation
acute exacerbation of chronic bronchitis
asthma
chronic obstructive pulmonary disease
community-acquired pneumonia
smoking cessation
ventilated nosocomial pneumonia
vitamin D insufficiency in cystic fibrosis patients
Amyotrophic Lateral Sclerosis (ALS)
arthritis (psoriatic, rheumatoid)
fibromyalgia
osteoarthritis (patellar, patella-femoral)
emesis (postoperative)
patient preoperative skin preparation
melanoma
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