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Draft Guidance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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