COVID-19 updates: Test for pooled samples, CTAP, Domestic inspections, FDA Insights podcasts, Laboratory and Manufacturer resources

 

Quest SARS-CoV-2 rRT-PCR test for pooled samples

Quest Diagnostics

Emergency Use Authorization for first diagnostic test use with pooled samples containing up to four individual swab specimens

  • Sample pooling allows for more people to be tested quickly using fewer testing resources
  • Samples collected from four individuals tested in pool or “batch” using one test, rather 4 tests
  • If pool is positive, each of the samples in that pool are tested again individually
  • Fewer tests are run overall, meaning fewer testing supplies and quicker test particulalry in areas with low prevalence, meaning most results are expected to be negative.

Package insert


Coronavirus Treatment Acceleration Program

The Coronavirus Treatment Acceleration Program (CTAP) to enable FDA to leverage cross-agency scientific resources and expertise to bear on COVID-19 drugs and biologics development and review

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Resumption of domestic inspections with new risk assessment system

COVID-19 Advisory Rating system (COVID-19 Advisory Level) to assist in determining when and where it is safest to conduct prioritized domestic inspections

  • Uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data
  • Phase of the State, statistics measured at the county level to gauge the current trend and intensity of infection
  •  Goal of restarting on-site inspections during the week of July 20

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FDA Insights podcasts

Insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics.

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COVID-19 Resources for Laboratories and Manufacturers

Emergency Use Authorizations for Medical Devices

EUA Authorized Serology Test Performance

Independent Evaluations of COVID-19 Serological Tests

Testing Supply Substitution Strategies: Download the slide show file (PPT – 1.5MB) and click Slide Show > From Beginning.

Reporting fraudulent products


Image credit: FDA

Marketing Authorizations: EndeavorRX digital therapy for ADHD, FINTEPLA for Dravet Syndrome, GALLANT defibrillator systems

EndeavorRx digital therapy

Akili Interactive

INDICATION FOR USE: Digital therapeutic indicated to improve attention function as measured by computerbased testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Tests of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include: clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.

DEVICE TYPE: Digital therapy device for Attention Deficit Hyperactivity Disorder. Software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment.

ADDRESSING UNMET NEED: First digital therapeutic intended to improve symptoms associated with ADHD. First game-based therapeutic granted marketing authorization by the FDA for any type of condition. 

PERFORMANCE & SAFETY:

  • Multiple studies in >600 children
  • Evaluated demonstrated improvements in attention function, as measured by TOVA, academic performance measures, and other assessment tools
  • No serious adverse events reported
  • Most common adverse events: Frustration, headache, dizziness, emotional reaction, and aggression

REGULATORY PATHWAY: De Novo classification

Reclassification order


FINTEPLA (fenfluramine) oral solution

Zogenix Inc

INDICATION: Treatment of seizures associated with Dravet syndrome in patients 2 years of age and older

MECHANISM OF ACTION: Exact mechanism for treatment of seizures unknown;
fenfluramine and metabolite, norfenfluramine, increase extracellular levels of serotonin and exhibit agonist activity at serotonin 5HT-2 receptors

ADDRESSING UNMET NEED: New therapy for Dravet syndrome- a life-threatening, rare and chronic form of epilepsy that is characterized by severe and unrelenting seizures despite medical treatment

EFFICACY & SAFETY:

  • Two clinical studies, n=202 subjects 2-18 years old; Fintepla vs placebo
  • Primary endpoint: Change from baseline in the frequency of convulsive seizures
  • Significantly greater reductions in convulsive seizures frequency with Fintepla within 3-4 weeks, remained consistent over the 14- to 15-week treatment periods
  • Boxed warning: Valvular heart disease (VHD) and pulmonary arterial hypertension (PAH)
  • Most common adverse reactions: Decreased appetite; drowsiness, sedation and lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue or lack of energy; ataxia, balance disorder, gait disturbance, blood pressure; drooling, salivary hypersecretion, pyrexia; upper respiratory tract infection; vomiting; decreased weight; risk of falls; and status epilepticus.

REGULATORY PATHWAY: NDA

  • Priority Review, Orphan Drug Designation
  • Schedule IV controlled substance
    • Restricted drug distribution program, REMS)
    • Special certification to dispense, cardiac monitoring with echocardiograms

Label


GALLANT implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices 

Abbott

INDICATION FOR USE: For automated treatment of life-threatening ventricular arrhythmias; also indicated to treat symptoms in patients who have congestive heart failure with ventricular dyssynchrony. In addition, dual chamber ICD and CRT-D devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial tachyarrhythmias.
MR Conditional ICDs and CRT-Ds are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury, death or device malfunction.
The myMerlinPulse™ mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices.

DESCRIPTION:

  • Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation; also intended to resynchronize right and left ventricles
  • Pairs with Abbott’s secure myMerlinPulse™, an iOS- and Android™- compatible mobile smartphone app that helps streamline communication between doctors and their patients
  • App provides people with access to data, device performance, and transmission history, which helps them take an active role in their healthcare
  • Through the app, physicians can continuously monitor their patients remotely allowing for identification of asymptomatic episodes as well as patient-triggered transmissions, which can lead to earlier intervention and reduce clinical burden

ADDRESSING UNMET NEED:  

  • 6.1 million people in US with cardiac arrhythmias, or abnormal heart rhythms
  • ICDs are used to help reduce the risks of life-threatening arrhythmias.
  • CRT-Ds can be used to restore the heart’s natural pattern of beating for patients with heart failure or in situations when the heart’s chambers beat out of sync

REGULATORY PATHWAY: PMA

Safety Information


Image credits: Akili, Zogenix, Abbott

COVID News: Hydroxychloroquine sulfate/ chloroquine phosphate revocation, Vaccine development guidance, Partnering with EU, Warning against methanol containing hand sanitizers

Revocation of EUA for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19

FDA believe’s the suggested dosing regimens for CQ and HCQ unlikely to produce an antiviral effect

  • Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated
  • Recent data from a randomized controlled trial showed no difference between HCQ vs. standard of care slone
  • Current U.S. treatment guidelines do not recommend the use of CQ or HCQ outside of a clinical trial; NIH guidelines now recommend against such use outside of clinical trial
  • Recent data from a large randomized controlled trial with HCQ showed no evidence of benefit for mortality or hospital length of stay or need for mechanical ventilation
  • Additionally, the serious cardiac adverse events and other serious side effects cause the risks to outweigh benefits

Frequently Asked Questions on the Revocation of the Emergency Use Authorization for Hydroxychloroquine Sulfate and Chloroquine Phosphate (PDF, 125 KB)

LETTER


Development and Licensure of COVID-19 vaccine

Recommendations :

  • Using different technologies such as DNA, RNA, protein and viral vectored vaccines
  • Help expedite vaccine development without sacrificing our standards for quality, safety, and efficacy
  • Guidance provides overview of key considerations chemistry, manufacturing and control, nonclinical and clinical data
  • Studies to directly evaluate the ability of the vaccine to protect humans from SARS-CoV-2 infection and/or disease

Final Guidance


Partnering with the European Union and Global Regulators on COVID-19

FDA, European Commission (EC) and European Medicines Agency (EMA) have a multitude of critical scientific and regulatory collaborations for COVID-19 response  

  • 30 technical expert groups, or “clusters”
  • Exchanging information on interpretation of data supporting regulatory decisions
  • Virtual bilateral meetings to review high-priority areas
  • Engagement with global regulators, under the International Coalition of Medicines Regulatory Authorities (ICMRA) forum, which is comprised of 28 regulatory authorities from around the globe
  • International collaborations in medical device work
  • READ

Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

Hand sanitizer products containing methanol, or wood alcohol

  • Often used to create fuel and antifreeze
  • Can be toxic when absorbed through the skin as well as life-threatening when ingested
  • Reported recent adverse events from adults and children including blindness, hospitalizations and death

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Webpage for a full list of FDA-tested and recalled hand sanitizers:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitzers-methanol


Image credit: FDA