Consumer Warning for Erectile Dysfunction Pills

The FDA confirmed that consumers have received these drugs, without a prescription, which contain 100 mg of sildenafil, the active ingredient in Viagra. This is a dangerous dosage strength for certain patients including the elderly and those with impaired liver and kidney function. When sildenafil interacts with nitrates in some prescription drugs, such as nitroglycerin, a person’s blood pressure can reach dangerously low levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Do not use these products. If you have used these products and became ill or otherwise experienced an adverse event, contact your health care provider. FDA continues to warn consumers that medications purchased from unapproved and/or unlicensed sources may be dangerous as they can be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe.

The label on the blister packs for these unapproved drugs states that the products are manufactured in India by Acme Generics. The label also bears the name Sun Pharma. FDA is concerned the seller may also be distributing to U.S. consumers unapproved tadalafil as a generic for the prescription drug Cialis.

Adverse Events
To date, FDA is not aware of any adverse events associated with these particular unapproved versions of sildenafil or tadalifil. Health care professionals and consumers should report any adverse events related to this product to FDA’s MedWatch. Adverse Event Reporting program by:
•  Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
•  Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.

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3D Printing for Medical Devices

3D printing is a process that creates a three-dimensional object by building successive layers of raw material.

Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI).  The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment or tools. It also enables manufacturers to create devices matched to a patient’s anatomy (patient-specific devices) or devices with very complex internal structures. These capabilities have sparked huge interest in 3D printing of medical devices and other products, including food, household items, and automotive parts.

In the picture, models have been 3D-printed for (left to right, top) a brain, blood vessel, surgical guide, and (bottom) medallion printed on FDA 3D printers.

Medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics. Due to its versatility, 3D printing has medical applications in:
• Medical devices – regulated by FDA’s Center for Devices and Radiological Health (CDRH)
• Biologics – regulated by FDA’s Center for Biologics Evaluation and Research
• Drugs – regulated by FDA’s Center for Drug Evaluation and Research

Medical device manufacturers should refer to FDA guidance documents and Quality Systems regulations for more information on specific applications.

Additional Resources (see link) are available, including:
• The 3Rs of 3D Printing: FDA’s Role
Learn how the FDA reviews and researches 3D printed medical products to protect the public health.
• How 3D Printers Work
A resource from the Department of Energy and includes descriptions of different types of printing processes
• NIH 3D Print Exchange
Offers a unique set of models, learning resources and tutorials to create and share 3D-printable models related to biomedical science. The goal of the project is to facilitate the application of 3D printing in the biosciences.
• American Society of the International Association for Testing and Materials (ASTM)
This is a collaborative, consensus organization that has published standards and test methods for additive manufacturing and 3D printing.
• America Make
A public private partnership whose members, including the FDA, are working together to innovate and accelerate 3D printing to increase our nation’s global manufacturing competitiveness.

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Working to Bridge Gaps in Rare Disease Product Development

There are approximately 7,000 rare diseases affecting an estimated 30 million people in the United States. Many
of these diseases are serious or life-threatening and it is estimated that half affect children. Unfortunately, most rare diseases still do not have approved therapies.  In 2018 we saw a record number of novel drugs and biologics approved for rare diseases. In particular, there were 35 novel drugs and biologics approved in 2018 with orphan drug designation. This is the highest number since the passage of the Orphan Drug Act in 1983.

These approvals included drugs and biologics utilizing programs to facilitate and expedite development and review of medical products to address unmet medical need. Among the many new orphan therapies in 2018, the FDA approved the first drug to treat patients with a rare, inherited form of rickets, and the first orally-administered drug to treat Fabry disease. The FDA also approved a new biologic for patients when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

The FDA will host a public meeting on April 29, 2019: ”Patient Perspectives of the Impact of Rare Diseases: Bridging the Commonalities.” This provides the opportunity to hear patients’ and caregivers’ perspectives on how rare diseases impact their daily lives and to assess commonalities that may help the Agency and medical product developers further understand and advance the development of treatments for rare diseases. While the differences between rare diseases are critically important, it is also important to assess commonalities to synergize product development in rare diseases.

Additionally the grant review process will be enhanced by providing grant reviewers with patient perspectives gleaned from listening sessions with patients about rare diseases. These enhancements will build on new priorities in grant review. Specifically, to address the unmet needs for rare diseases, the Office of Orphan Products has made meaningful changes to both funding focus and review process for the Clinical Trial and Natural History grants programs. They are focusing on studies of rare diseases with unmet needs that use efficient and innovative trial designs, such as adaptive and seamless trial designs, use of modeling and simulations, incorporation of real world data, and basket and umbrella trials studying multiple rare diseases/products. Applicants are asked to incorporate patient input into their research proposals.

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Clinical Trial of B244 for the Treatment of Pediatric Atopic Dermatitis

AOBiome Therapeutics, Inc. a clinical-stage microbiome company focusing on the research and development of therapeutics for dermatological conditions, announced the administering of its lead product candidate, B244, to the first patient in the Company’s Phase 1b clinical trial to treat pediatric patients with atopic dermatitis (eczema). Data from the First Pediatric Study are Anticipated in the Second Half of 2019.

“There is a significant medical need for new therapies to treat children with atopic dermatitis due to the high and increasing incidence of the disease and the limited number of safe and efficacious options to treat this sensitive population,” said President & CEO, Todd Krueger.  In the United States, 13% of children (or 9.6 million) under the age of 18 years suffer from eczema. Of these, approximately one third have moderate to severe eczema. Additionally, many children who suffer from atopic dermatitis in their youth also go on to disproportionally suffer from certain diseases later in life, including 43% of children with severe atopic dermatitis before the age of 8 developing asthma and 45% developing allergic rhinitis according to one recent study.

The clinical trial is an open-label, multicenter, Phase 1b study of B244, a first-in-class, topical formulation of beneficial ammonia oxidizing bacteria (“AOB”), delivered as a topical spray twice daily and is designed to assess safety and tolerability in 36 pediatric patients aged 2 to 17 years with mild to moderate atopic dermatitis over a 28-day period. The AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

“Our goal is to alleviate both the symptoms that are associated with atopic dermatitis and to utilize AOB’s nitric oxide-mediated anti-inflammatory abilities coupled with its capability to reduce levels of pathogenic bacteria as a dual-modality approach to treatment,” said CMO, Dr. Judith Ng Cashin, M.D. “Current therapies for atopic dermatitis can cause side effects such as stinging, burning, and thinning of skin, especially in pediatric patients. B244’s innovative nature represents a novel therapeutic opportunity to address the significant market need and to impact the lives of patients.”

In addition to the ongoing pediatric study, AOBiome is currently conducting a Phase 2 clinical trial investigating B244 for the treatment of adult atopic dermatitis with expected top-line data readout in 2019. See: www.clinicaltrials.gov.

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