FDA Brief, Week of December 14th, 2015 – Drug and Device Digest

Issues to consider when it comes to keeping your pet safe from holiday hazards. Youtube

FDA Voice

precisionFDA Launches precisionFDA to Harness the Power of Scientific Collaboration

By: Taha A. Kass-Hout, M.D., M.S. and Elaine Johanson


  • Collaboration between industry, academia, government
  • Online, cloud-based portal on  “reading” DNA  – next-generation sequencing (or NGS)
  • Look for meaningful DNA differences for disease risk, treatment response, tailor personalized treatment
  • Leverages experience with establishing openFDA – easy access to public datasets



2016 CDER PRIORITIES:  Janet Woodcock M.D., Director, CDER, FDA


Front Burner



PDUFA 6 agreements

Advertising /Promotion  regulations

Prescription Opioid Epidemic

Sentinel Network  and Drug Safety

Drug Supply Chain, Imports

Drug Label Improvement, Pregnancy & Lactation Rule

Biomarkers, Accelerated Approval, Qualification

Personalized Medicine

Breakthrough Therapies

Qualitative Benefit/Risk assessment

Electronic  Health Data, Clinical Evidence

Patient-focused Drug Development

CV safety studies for Diabetes and Obesity

Pediatric Evaluation for non- PREA/BPCA drugs

Bayesian Statistics, Adaptive Designs, Modeling

PFUFA and meeting goals

FOI and reducing backlog

 Advisors and Consultants and AC meetings

IT assessment

  • Supporting Regulatory Operations and strengthening Electronic Submissions Gateway (ESG)
  • Electronic Regulatory Submissions
  • Data Standards
  • Metrics and Measures
  • Communications and Technical Interactions

Objectives, 2015 Milestones and Accomplishments, Future Milestones


Safety reporting

  • Timely and Effective (with causality assessment) reporting
  • Key elements of a systematic approach to safety surveillance
    • Safety Assessment Committee
    • Safety Surveillance Plan describing policies and procedures
  • Recommendations for :
    • Committee Organization
    • Safety Assessment practices
    • Prospective development of Safety Surveillance Plans

Draft Guidance

 FDA approved

merck   Bridion (sugammadex)


Indication :  Reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.

Unmet need:

  • Neuromuscular blocking drugs (e.g. rocuronium bromide, vecuronium bromide) cause temporary paralysis by interfering with nerve impulse transmission to muscle
  • Used to paralyze vocal cords for tracheal intubation, used as general anesthesia during surgery, used to prevent automatic breathing when a patient is on a ventilator
  • Need for treatment option to help patients recover sooner from intubations and ventilations during surgery

Reg Pathway: NDA submitted in 2007, Complete Response Letter, Approval of responses to Action Letter

Mechanism of Action: As a modified gamma cyclodextrin, forms a complex with the neuromuscular blocking agents rocuronium and vecuronium and reduces availability to bind to receptors in  neuromuscular junction.


  • 3 Multicenter, randomized, parallel-group studies vs neostigmine or succinylcholine (n=456), post-surgical patients with moderate and deep blockage
  • Primary Endpoint : Time from start of administration to recovery of twitch responses to train-of-four (TOF)  ratio of 0.9 (correlates with  recovery from neuromuscular blockade)
  • Study 1 Moderate Blockade (vs neostigmine) :  Faster recovery,  1.4 min  vs  21.5 min
  • Study 2 Deep Blockade (vs neostigmine) : Wider range of recovery; median times comparable
  • Study 3 (blockade by succinylcholine vs blockade by rocuronium followed by Bridion) : Faster Recovery, 4.4 min vs 7.2 min


  • Possibility of a hypersensitivity reaction or anaphylaxis – intervene as appropriate.
  • Marked bradycardia some leading to cardiac arrest – monitor closely and treat appropriately
  • Most common adverse reactions: Vomiting, low blood pressure (hypotension), pain, headache and nausea.
  • May reduce effect of hormonal contraceptives

lilly Basaglar (insulin glargine )


Indication:  Improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus  and in adults with type 2 diabetes mellitus.

Unmet need:

  • 21 million people in US diagnosed with diabetes; increases risk of heart disease, blindness, nerve and kidney damage
  • Need to expand availability of treatment options for long-acting insulin products

Reg Pathway:  FIRST “follow-on” insulin glargine product . 505(b)(2) application : Comprised of reference to FDA’s approval of Lantus (insulin glargine injection)  and additional clinical studies. Tentative approval in 2014.

Mechanism of Action:  Lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.


  • Comparability to other insulin glargine products: 2,327 adults and 349 pediatric patients with type 1 diabetes mellitus and 1,563 adult patients with type 2 diabetes mellitus. Basaglar similar to other products.
  • The Basaglar-specific data : 2 clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus, respectively.


  • Insulin Class effect : Severe, life-threatening, generalized allergic reactions, including anaphylaxis, or generalized skin reactions, angioedema, bronchospasm, hypotension and shock
  • Common adverse reactions: Hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema (fluid retention) and weight gain.


LifevestLifeVest Wearable Cardioverter Defibrillator

Zoll Lifecor Corporation, Pittsburgh, Pennsylvania. 

Intended Use : Wearable cardioverter defibrillator to monitor and treat cardiac arrhythmias in children (restrictions must have a chest circumference of 26 inches and weigh at least 18.75kg). Has been previously approved for use in adults (> 18 years of age).

Unmet need :

  • A life-threatening abnormal heart rhythm- ventricular fibrillation (V-fib) or ventricular tachycardia (V-tach), most common cause of sudden cardiac arrest and death
  • Rapid treatment with a defibrillator can save lives
  • For children – Need for defibrillator worn by patients with constant monitoring of arrhythmias and provision of appropriate response

Reg Pathway: PMA supplement, based on published studies and Registry of 248 patients

Description :

  • 2 main components: (i) electrode belt and garment surrounding chest,(ii) monitor around waist
  • Responds automatically if it senses the need to deliver a shock, restoring a life-sustaining heartbeat.


checkme proCheckme Pro portable health monitor

Viatom Technology, Taiwan, 510K

  • One-lead ECG recording, pulse oximetry, temperature measurement, and movement sensing
  • Provides QRS duration, ST segment, and rhythm analysis for basic cardiac monitoring
  • Track SpO2 up to 10 hours during sleep
  • Records can be reviewed by Physician

gruveGRUVE anterior cervical plate system

Lifespine, Huntley, IL, 510K

  • Surgical treatment of spine disorders
  • Allows extreme bone screw angulation, large graft windows, in addition to a tactile and visual confirmation of the locking mechanism during final screw placement


NxTAG NxTag Respiratory Pathogen Panel

Luminex, Austin TX, 510K

  •  Simultaneous detection of 20 respiratory pathogens in a single closed-tube system, including atypical bacteriaChlamydophila pneumoniae and Mycoplasma pneumonia
  • Minimal hands-on time with no upstream reagent preparation, simplified workflow
  • Synct software for data analysis and reporting






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