FDA Updates for Health Professionals

• ANNOUNCEMENTS
• OPPORTUNITIES FOR COMMENT / GUIDANCES
• PRODUCT APPROVALS & CLEARANCES
• PRODUCT SAFETY
• UPCOMING MEETINGS
• RESOURCES

ANNOUNCEMENTS

FDA 2015: A Look Back (and Ahead) – Part 3: Food, Tobacco, and Antimicrobial Resistance We saw great progress in 2015, thanks to collaborative efforts across our government and with our international partners, in combating antibiotic resistance. If left unchecked, this growing problem threatens to turn back the clock on decades of progress in infectious disease control and medical discoveries, drive health care costs higher, and increase human disease and death. More information

FDA 2015: A Look Back (and Ahead) – Part 2: Medical Product Safety and Oversight Stephen M. Ostroff, M.D., Acting Commissioner of Food and Drugs, reviews FDA’s impact on medical product safety and oversight, including the response to Ebola, addressing transmission of infections from Duodenoscopes, drug compounding, and opioid abuse and addiction. More information

FDA engages stakeholders on opportunities to improve hearing aid usage and innovation

FDA announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States. The FDA will convene stakeholders for a public workshop and has re-opened a public comment period on a draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products (PSAPs).
More information

FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

FDA issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP. More information

US Marshals seize dietary supplements containing kratom

FDA announced that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured for and held by Dordoniz Natural Products LLC, is marketed under the brand name RelaKzpro. Mitragyna speciosa, commonly known as kratom, is a botanical substance that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss and constipation. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Request for comment by February 22, 2016: Guidance: Emergency Use Authorization of Medical Products FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. This notice solicits comments on the proposed extension of the collection of information related to emergency use authorizations by the Agency. More information

Establishment of a Public Docket; Clinical Trial Designs in Emerging Infectious Diseases

FDA held a workshop on “Clinical Trial Designs in Emerging Infectious Diseases” in partnership with the National Institute of Allergy and Infectious Diseases, the HHS Office of the Assistant Secretary for Preparedness and Response, and the Centers for Disease Control and Prevention as a step in collecting information. FDA is establishing a public docket to receive input on clinical trial designs in emerging infectious diseases. Interested parties are invited to submit comments, supported by research and data, regarding clinical trial designs.
More information

PRODUCT APPROVALS & CLEARANCES

FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers FDA approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.  More information

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

PRODUCT SAFETY

Need Safety Information? For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here.

Children's Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid by Perrigo Company: Recall - Potential Defect with Dosage Cup Perrigo announced a voluntary product recall in the US to the retail level of 2 batches of its children's guaifenesin grape liquid (100mg/5 mL) and 3 batches of its children's guaifenesin DM cherry liquid (100mg guaifenesin and 5mg dextromethorphan HBr/ 5 ml) sold in 4 oz. bottles, with dosage cup in a box, under multiple store brand product names. Some packages contain an oral dosing cup with incorrect dose markings. More information

December 2015 Drug Safety Labeling Changes 

Medwatch posted the December 2015 Drug Safety Labeling Changes, which included 31 products with revisions to the Prescribing Information. More information

Pleural and Pneumopericardial Drainage Sets by Stryker Fuhrman - Class I Recall - Catheter May Break During Insertion

Stryker Sustainability Solutions received two reports that the catheter included in the Drainage Set broke off in the pleural cavity while inserting the device into the patient. Both cases resulted in the need for medical intervention. This issue could cause serious patient injury or death. More information

Multiple Products by R Thomas Marketing: Recall - Undeclared Drug Ingredient

Products tested by the FDA were found to contain sildenafil, a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED). This undeclared active ingredient poses a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. More Information

L.G Compounded Asafoetida Powder by Shakti Group: Recall - Potential Contamination with Salmonella

Salmonella can cause fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.More information

Evita V500 and Babylog VN500 Ventilators by Dräger: Class I Recall - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly

Dräger recalled the PS500 battery power supply because a software issue causes shorter than expected battery run times. The software issue with the power supply also prevents the appropriate alarm from sounding 5 minutes before the battery runs out of power and the device shuts down. If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death. More Information

Magnesium Sulfate in Water for Injection by Hospira: Recall - Incorrect Barcode Labeling on the Primary Container

Potential for delay in treatment that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise. More Information

Surgical Convenience Packs and Trays by Customed, Inc.: FDA Safety Communication - Do Not Use

The integrity, safety and efficacy cannot be assured because of inadequate testing. Use of these products pose a risk of serious adverse health consequences, such as infection and death. More Information

Baxter IV Solutions: Recall - Potential Presence of Particulate Matter

Baxter International Inc. announced a voluntary recall of two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint.  Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, stroke, heart attack or damage to other organs such as the kidney or liver.More Information

Noxafil (posaconazole): Drug Safety Communication - Dosing Errors when Switching between Different Oral Formulations; Label Changes Approved

FDA cautioned that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (posaconazole) have resulted in dosing errors. To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose. Direct mg for mg substitution of the two formulations can result in drug levels that are lower or higher than needed to effectively treat certain fungal infections. More information

FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

The FDA issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP. The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. More information

UPCOMING MEETINGS

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.

Vaccines and Related Biological Products Advisory Committee Meeting (Jan 14)

The committee will hear updates of the research program in the Laboratory of Method Development, Division of Viral Products, Center for Biologics Evaluation and Research, FDA. The committee will meet by teleconference. More information

Allergenic Products Advisory Committee Meeting (Jan 21)

The committee will discuss safety and effectiveness data, including challenge study endpoints, for licensure of food allergy immunotherapy products, and the clinical development of aeroallergen immunotherapy products for the prevention of respiratory allergic disease. More information

Public Workshop – Moving Forward: Collaborative Approaches to Medical Device Cybersecurity (Jan 21-22)

FDA, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department of Health and Human Services and the Department of Homeland Security, seek to bring together diverse stakeholders to discuss complex challenges in medical device cybersecurity that impact the medical device ecosystem. The purpose of this workshop is to highlight past collaborative efforts, increase awareness of existing maturity models which are used to evaluate cybersecurity status, standards, and tools in development, and to engage the multi-stakeholder community in focused discussions on unresolved gaps and challenges that have hampered progress in advancing medical device cybersecurity. More information

Public Workshop – Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy (Jan 25)

The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA’s process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. More information

The Twentieth FDA CASSS Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products  (Jan 26)

Objectives of this meeting include discussing the latest bio-analytical methods and their practical application to biotechnological pharmaceuticals (BPs) and other health-related products, and soliciting feedback from industry, academia, government, and other stakeholders on advancements in bio-analytical methods and their application to BPs. More information

Eighth Annual Sentinel Initiative Public Workshop (Feb 3)

Convened by the Center for Health Policy at the Brookings Institution and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an update on the state of FDA’s Sentinel Initiative, including an overview of the transition from the Mini-Sentinel pilot to the full Sentinel System and key activities and uses of the Sentinel System accomplished in 2015. In addition, panelists will discuss the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. This workshop will also engage stakeholders to discuss current and emerging Sentinel projects. Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, will provide the morning keynote address. More information

Psychopharmacologic Drugs Advisory Committee Meeting (Feb 3)

The committee will discuss cognitive dysfunction in major depressive disorder (MDD). This is an evolving concept and experts in the field have not yet reached consensus as to whether cognitive dysfunction in MDD is a distinct entity. The committee will consider the clinical presentation of cognitive dysfunction in MDD, as well as methods for assessing this condition. The committee will also discuss new drug application 204447/supplemental new drug application 006, for the effectiveness of vortioxetine for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, Inc. More information

Risk Communication Advisory Committee Meeting Announcement (February 16-17)

The Committee will discuss recent developments in risk communications and related sciences, and possible approaches and applications in the context of FDA communications. More information

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Feb 18)

The Committee will discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology.  Specifically, the Committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for postapproval study collection.More information

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (Feb 19)

The Committee will discuss the premarket application for the DIAM Spinal Stabilization System.  The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to moderate lumbar degenerative disc disease (DDD) at a single level from L2-L5.  More information

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (February 25-26)

On February 25, 2016, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for "TOPAS Treatment for Fecal Incontinence," by ASTORA Women's Health, LLC. The device is a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). On February 26, 2016, during session I, the committee will discuss and make recommendations regarding the reclassification of urogynecologic surgical mesh instrumentation from class I to class II. More information

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch

Comunicaciones de la FDA sobre la seguridad de los medicamentos en español

Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible  para proporcionar  versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information endruginfo@fda.hhs.gov. Comunicaciones de la FDA

MedWatchLearn - Practice Reporting to FDA! This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA.More information

FDA Expert Commentary and Interview Series on Medscape

As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices More information  

Cardiovascular and Endocrine Liaison Program The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. More information

FDA Basics Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information FDA Voice FDA voice is the official blog from FDA's senior leadership and staff.More information

Medical Product Safety Network (Medsun)

Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns.  The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety.  More information