Capture.JPGAdcetris (brentuximab vedotin) injection

Seattle Genetics

EXPANDED INDICATION: Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), in combination with cyclophosphamide, doxorubicin, and prednisone

ADDRESSING UNMET NEED:

  • First approval for treatment of newly diagnosed PTCL
  • Use of new Real-Time Oncology Review (RTOR) program to complete approval more quickly; access key data prior to the official submission of application allowing review team to begin review prior to the application’s actual submission

EFFICACY: 

  • Trial, n=452 patients with certain PTCLs who received either Adcetris plus chemotherapy or a standard chemotherapy (CHOP) as first-line treatment
  • Progression-free survival:  Significantly longer (hazard ratio 0.71, P-value 0.01) in the Adcetris arm (median 48 months, compared to 21 months with CHOP)
  • Survival and overall response rates were also significantly better in the Adcetris arm

SAFETY:

  • Boxed Warning: JC virus infection resulting in PML
  • Most common side effects: Peripheral neuropathy, nausea and vomiting, diarrhea, low white blood cell counts, fatigue, mouth sores, constipation, hair loss, fever and anemia
  • Monitor for infusion reactions, life-threatening anaphylaxis, neuropathy, fever, gastrointestinal complications and infections, tumor lysis syndrome,  serious skin reactions, pulmonary toxicity and hepatotoxicity.

EXPANDED LABEL


Capture.JPGDPP Ebola Antigen System

ChemBio Diagnostic

INTENDED USE: The is a rapid, single-use immunochromatographic test intended for the qualitative detection of VP40 protein from Ebola virus (species Zaire ebolavirus and hereafter referred to as Ebola virus) in capillary “fingerstick” whole blood, EDTA venous whole blood, and EDTA plasma

ADDRESSING UNMET NEED:

  • Rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus)
  • Second Ebola rapid antigen fingerstick test available
  •  Collaboration with  Federal, international and industry partners to assist in global response to Ebola outbreak in Democratic Republic of Congo

DESCRIPTION: 

  • Single-use immuno-chromatographic, rapid test developed on Chembio’s patented DPP® technology
  • DPP® Micro Reader which is used to interpret test results

REGULATORY PATHWAY: Emergency Use Authorization

PACKAGE INSERT


CapturepicoAMH ELISA Menopause Test

Ansh Labs

INDICATION FOR USE: Enzyme-linked immunosorbent assay (ELISA) for the in vitro quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum. It is intended to be used as an aid in the determination of menopausal status in women between 42 and 62 years of age. This assay should only be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make diagnostic or treatment decisions. It is intended for in vitro diagnostic use and for prescription use only

ADDRESSING UNMET NEED: 

  • Diagnostic results about a woman’s menopausal status may prompt discussions about preventative care for women experiencing menopausal symptoms
  • Can help inform discussions about preventative care e.g. prevent loss in bone mineral density or to address cardiovascular disease, both of which increase after menopause

GENERIC DEVICE TYPE: Menopause test system

  • In vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women

EFFECTIVENESS AND SAFETY:

Capture.JPG

  • Data from multi-center, longitudinal Study of Women’s Health Across the Nation (SWAN), n= 690 women, aged 42 to 62
  • PicoAMH Elisa test performed reasonably well
    • determining AMH levels of AMH in blood
    • identifying women who had their last menstrual period
    • identifying women who were more > five years away from last menstrual period

RISKS & MITIGATIONS:

  • Incorrect test results: General controls and special controls
  • Incorrect interpretation of test results: General controls and special controls

REGULATORY PATHWAY: De Novo request

  • Regulation Number: 21 CFR 862.1093
  • Regulation Name: Menopause test system
  • Regulatory Class: Class II
  • Product Code: QDH

CLASSIFICATION ORDER


Capture.JPG

INNOVO 

Atlantic Therapeutics Group

INDICATION FOR USE: Transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females. Indicated for prescription use only.

GENERIC DEVICE TYPE: Transcutaneous electrical continence device

  • Consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence

EFFECTIVENESS AND SAFETY:

  • Two randomized controlled trials in EU and US
  • US trial: 87.2% of patients were dry or mild of after a 12-week treatment period1, with 93% of patients experiencing improvement in 4 weeks

RISKS & MITIGATIONS

  • Pain or tissue damage due to overstimulation: Non-clinical performance testing
    Software verification, validation, and hazard analysis, Electrical safety testing, Labeling
  • Adverse tissue reaction: Biocompatibility evaluation
  • Electrical shock or burn: Electrical safety testing, Software verification, validation, and hazard analysis, Labeling
  • Device failure due to electromagnetic interference: Electromagnetic compatibility (EMC) testing, Software verification, validation, and hazard analysis, Labeling
  • Use error that may result in user discomfort, injury, or delay in treatment: Software verification, validation, and hazard analysis, Labeling

REGULATORY PATHWAY: De Novo request

  • Regulation Number: 21 CFR 876.5330
  • Regulation Name: Transcutaneous electrical continence device
  • Regulatory Class: Class II
  • Product Code: QAJ

CLASSIFICATION ORDER


Image Credits: Seattle Genetics, ChemBio, Ansh Labs, Atlantic Therapeutics

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s