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FDA Updates for Health Professionals- April 18, 2018

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FDA Updates for Health Professionals

April 18, 2018


New efforts to enhance and modernize the FDA’s approach to medical device safety and innovation- Statement from FDA Commissioner Scott Gottlieb, M.D.
Advances in material science, digital technology and advanced manufacturing are contributing to an unparalleled period of invention in medical devices. New devices offer more opportunities to improve health than at any time. Last year, the FDA approved a record number of novel devices. This reflects an advancing pace of innovation that’s resulting in many more potentially lifesaving new medical products. This includes the first artificial pancreas and the first blood test to evaluate traumatic brain injury.

FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine
The FDA took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products. These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses. Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at least two deaths in otherwise healthy individuals.

FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
The FDA finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments. The guidances provide recommendations for designing, developing, and validating tests that use the technology, called next generation sequencing (NGS), and will play an important role in the continued advancement of individualized, genetic-based medicine.

FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
The FDA permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans living with diabetes and the leading cause of vision impairment and blindness among working-age adults.

FDA clears first contact lens with light-adaptive technology
The FDA cleared the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are soft contact lenses indicated for daily use to correct the vision of people with non-diseased eyes who are nearsighted (myopia) or farsighted (hyperopia). They can be used by people with certain degrees of astigmatism, an abnormal curvature of the eye.

FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information
The FDA issued an order to restrict the sale and distribution of the Essure device to ensure that all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions. The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device. The FDA is requiring a unique type of restriction, using its authority to restrict the sale and distribution of a device to impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness. The FDA is committed to continuing to use its full authorities to ensure the post-market safety of medical products.

FDA seeks comments on Expansion of the Abbreviated 510(k) Program by July 11th, 2018.
This guidance expands the potential use of the Abbreviated 510(k) Program, allowing for less burdensome demonstrations of substantial equivalence for certain device types while maintaining the statutory standard for demonstrating substantial equivalence. The guidance describes an optional pathway for certain, well-understood device types, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate the device is as safe and effective as a legally marketed device (predicate device). The FDA believes that least burdensome principles should be widely applied to all activities in the premarket and postmarket settings to remove or reduce unnecessary burdens so that patients can have earlier and continued access to high quality, safe, and effective devices.

Protecting Public Health- Office of Regulatory Affairs (ORA)
ORA Maximizes Compliance of FDA Regulated Products and Minimizes Risks Associated with Those Products. How many arrests did OCI
 make last year? How many warning letters were issued? Learn all about FDA ORA 2017 achievements.



FDA approves new therapy for rare inherited form of rickets
The FDA approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone growth and development in children and adolescents and problems with bone mineralization throughout a patient’s life.

For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed


Epic Products, LLC,  Euphoric Capsules: Recall- Presence of Undeclared Sildenafil and Tadalafil
Overland Park, KS, Epic Products, LLC is voluntarily recalling all lots of Euphoric capsules, packaged in 1 count blister cards, 3 count bottles, and 12 count bottles to the consumer level. FDA analysis found samples of Euphoric to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterase 5-inhibitors (PDE-5 inhibitors), used to treat male erectile dysfunction (ED). The presence of sildenafil and tadalafil in Euphoric renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.

Rhino 69 Extreme 50000: Recall- Presence of Active Ingredient 'Tadalafil'
AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.
AMA Wholesale Inc. has not received any reports of adverse events related to this recall.
Consumers who take dietary supplements for erectile dysfunction could have underlying cardiovascular disease (from diabetes, hypertension, and others). Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE5 inhibitors can lead to fatal cardiovascular collapse.

Vuse Vibe Power Units: Recall- Malfunctioning Batteries
R.J. Reynolds Vapor Company has voluntarily initiated a nationwide safety recall of all Vuse Vibe power units. The Company initiated the recall after receiving consumer complaints about malfunctioning batteries, which may cause the power unit to overheat and create a fire risk. The Company notified the U.S. Food and Drug Administration regarding the issue and will be working directly with the Agency on this voluntary recall.

Coastal Meds: Recall of All Products Marketed as Sterile- Visible Particles
FDA is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some of the drug vials for injection.
During FDA’s recent inspection of Coastal Meds, investigators observed visible particulates and poor sterile production practices which further raise concerns about particulates in Coastal Meds’ drug products intended for injection.

For important safety information on human drugs, medical devices, dietary supplements and more, or to report an adverse event or problem with a medical product, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program.


FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees. Click on "more information" for details about each meeting.

Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.


Peripheral and Central Nervous System Drugs Advisory Committee Meeting (Apr 19)
The committee will discuss new drug application (NDA) 210365, cannabidiol oral solution, sponsored by GW Pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

FDA/OCE Public Meeting on Relevant Molecular Targets in Pediatric Cancers: Applicability to Therapeutic Investigation FDARA 2017 (Apr 20)
The FDA Oncology Center of Excellence will hold a public meeting to review and discuss a provisional list of molecular targets to which drugs are being developed for adult cancer indications but which may also be relevant to the growth and/or progression of a cancer which occurs predominantly in children thereby providing a possible rationale for early pediatric evaluation. This meeting is intended for multi-stakeholder participation and input to the Food and Drug Administration as it responds to its FDARA mandate to develop, post on the FDA website, and update regularly such a list to guide sponsors as to which molecular mechanism of action-specific targeted cancer drugs might be considered for early evaluation in children.

Arthritis Advisory Committee Meeting (Apr 23)
The committee will discuss the new drug application (NDA) 207924, for baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.  The discussion will include the following: efficacy, safety, including the risk of thromboembolic adverse events, dose selection, and overall risk benefit considerations.

12th Annual FDA/DIA Biostatistics Industry and Regulator Forum 2018 (Apr 23-25)
This meeting is intended to be an open forum for the timely discussion of topics of mutual interest to statisticians and clinical trialists who develop new drugs and biologics. A primary focus for this meeting will be to establish an on-going dialogue between industry and regulatory agencies regarding the role of statisticians in implementing the goals and commitments outlined in the sixth authorization of the Prescription Drug User Fee Act.


Antimicrobial Drugs Advisory Committee Meeting (May 2)
The committee will discuss new drug application (NDA) 210303 for plazomicin, sponsored by Achaogen Inc., for the proposed indications for the treatment of complicated urinary tract infections and blood stream infections in adults.

Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee Meeting (May 3)
The committees will discuss new drug application (NDA) 209904, for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.

FDA Drug Topics: Protecting Patients – Pharmacists Requirements under the Drug Supply Chain Security Act (May 8)
FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is presenting a series of continuing education webinars targeting the needs of all health care professionals.

Tissue Agnostic Therapies: Regulatory Considerations for Orphan Drug Designation; Public Workshop (May 9)
The FDA is holding a public workshop to discuss factors FDA should consider when evaluating drugs for orphan designation that treat a tissue agnostic disease or condition in oncology, and additional factors related to orphan exclusivity FDA should consider when approving a product with a tissue agnostic indication.

Endocrinologic and Metabolic Drugs Advisory Committee Meeting (May 10)
The committee will discuss the safety and efficacy of new drug application (NDA) 210645, for volanesoren solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc. The proposed indication is as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.

FDA Grand Rounds spotlights stakeholder opportunities in FDA predictive toxicology roadmap (May 10)
The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute presentation is followed by questions from the audience.

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee (May 22)
The committees will be asked to discuss new drug application (NDA) 209588, for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The committees will also be asked to discuss whether this product should be approved.

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