FDA Updates for Health Professionals

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

ANNOUNCEMENTS

Senate Confirmation of Dr. Robert M. Califf A statement from Dr. Stephen Ostroff: Today the U.S. Senate voted in support of the confirmation of Dr. Robert Califf, M.D. to be Commissioner of U.S. Food and Drug Administration. Dr. Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher, and leader in the fields of science and medicine.  He understands well the critical role that the FDA plays in responding to the changes in our society while protecting and promoting the health of the public, across the many areas we regulate – and I am confident that our public health and scientific contributions will further grow under his exceptional leadership. More information

FDA Releases Online Continuing Education Course on Biosimilars

FDA released an online continuing education (CE) credit course for health care professionals about biosimilars: “FDA Overview of Biosimilar Products.” The 90 minute course shares important information about the new type of biological product to help health care professionals make informed decisions when considering, prescribing, or dispensing biosimilar products.  The course also provides a general review of FDA’s process for biosimilar product development programs. More information

Clarifying What We Mean When We Talk About Biomarkers: An NIH/FDA Joint Leadership Council Success What if there was a more uniform way to convey key technical terms to help advance scientific progress? Thanks to the Biomarkers, Endpoints, and other Tools (BEST) Resource, we’re one step closer to that goal. Now available on the National Center for Biotechnology Information’s Bookshelf, the BEST Resource was developed through a collaboration of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). It includes a glossary of terms and definitions that will ensure the consistency and clarity needed to drive progress in biomedical research and clinical care. More information

Emergency Preparedness - Keeping Medications Safe

How can you prepare for the next winter storm? FDA announces the release of their newest Drug Info Rounds video, Emergency Preparedness – Keeping Medications Safe. In four minutes, FDA pharmacists discuss emergency plans that should be in place for medications and medical supplies.More information

FDA issues recommendations to reduce the risk for Zika virus blood transmission in the United States

As a safety measure against the emerging Zika virus outbreak, FDA issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection. More information

What is FDA Doing to Improve the Health of African-Americans?

Every February, we celebrate Black History Month – a time to reflect, celebrate, and honor the contributions of African-Americans to our society. We know that achieving and maintaining good health is a long-standing issue for this group, many of whom may experience worse health outcomes in critical areas like heart disease and diabetes. But, we want to focus on the positive and provide consumers with health education materials to support healthy behavior changes. It’s true that the health equity gap has narrowed over time, but there is still significant room for improvement. More information

CBER’s Laboratory Quality System Management Helps Keep Biological Product Standards High

Part of the vision of the Center for Biologics Evaluation and Research (CBER) is to strengthen the Center as the preeminent regulatory organization for biologics. One way CBER is achieving this: Through the work of the Office of Compliance and Biologics Quality (OCBQ) and the Office of Vaccines Research and Review (OVRR).  More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems FDA is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.More information

Patient and Medical Professional Perspectives on the Return of Genetic Test Results and Interpretations

FDA announced a public workshop entitled “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.” The purpose of this public workshop is to understand patient and provider perspectives on receiving potentially medically relevant genetic test results. The topic(s) to be discussed will focus on better defining the specific information patients and providers prefer to receive, with an emphasis on the type(s) and amount of evidence available to interpret the results for medical purposes, how those results should be returned, and what information is needed to understand the results in the event that they could effectively aid in medical decision making. Comments requested by March 31, 2016. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves Briviact to treat partial onset seizures FDA approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.  More information

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

PRODUCT SAFETY

Class I Recall: Oxylog 2000 Plus, 3000, and 3000 Plus Emergency Transport Ventilators by Dräger Medical - System Error May Lead to a Halt in Ventilation Therapy Dräger is recalling the Oxylog Emergency Transport Ventilators because an electrical issue may cause the device to stop working if the control knobs (adjustment potentiometers) are not regularly used.  More information FDA Alert: Syrspend SF and Syrspend SF Grape Suspending Agents by Fagron-Microbial Contamination with Yeast FDA is alerting compounding pharmacies of the voluntary recall of certain lots of SyrSpend SF and SyrSpend SF Grape suspending agents used in compounding of various oral liquid drug products, due to the presence of yeast (Candida galli). More information

Recall: Central Venous Catheters and Pressure Monitoring Sets and Trays by Cook Medical - Catheter Tip Fracture and/or Separation

During an internal inspection, a catheter exhibited the potential for catheter tip fracture and/or separation. Further investigation revealed that the technique used by the product assembler while tipping the catheter likely contributed to this nonconformance. No reports of illness or injury have been associated with this issue to date.  More information

Recall: Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9 percent Sodium Chloride by Pharmakon Pharmaceuticals - Super-potent Product

FDA is alerting health care professionals of a voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride, 1 mL syringe, CII, for intravenous use made and distributed by Pharmakon Pharmaceuticals, in Noblesville, Indiana, because the product is super-potent. Pharmakon initiated the voluntary recall on February 11, 2016, after receiving laboratory results showing the product was super-potent.  More information

Recall: 0.9 Percent Sodium Chloride Solution for Irrigation by Baxter

- Presence of Particulate Matter

Baxter International is voluntarily recalling one lot of 0.9% Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle solution - Lot G120162, expiration 11/30/2018 - to the hospital/user level. This product is being recalled due to a customer complaint prior to use for the presence of particulate matter, identified as an insect. More information

FDA Safety Communication: ED-3490TK Video Duodenoscope by Pentax

- Pentax Validates Reprocessing Instructions

PENTAX has issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling. The FDA reviewed these updated reprocessing instructions and the validation data and recommends that facilities using PENTAX ED-3490TK Video Duodenoscopes train staff on the updated instructions and implement them as soon as possible. More information

January Drug Safety Labeling Changes

Pharmacists in the Office of Health and Constituent Affairs reviewed January 2016 labeling changes to inform you of 26 products with safety revisions to prescribing information. More information

Endoscope Washer/Disinfectors by Custom Ultrasonics: Safety Communication - FDA Recommends Health Care Facilities Transition to Alternate Reprocessing Methods

Because Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection, the Agency continues to recommend that health care facilities using Custom Ultrasonics AERs transition to alternative methods to reprocess flexible endoscopes as soon as possible, as emphasized in its November 13, 2015 Safety Communication.More information

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.

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.

Science Board to the FDA Meeting (Mar 1)

The Science Board will hear about and discuss: (1) the role of opioids in pain management; (2) scientific challenges facing FDA in supporting the development of pain medications, including opioids, that have reduced risks of being abused; (3) scientific challenges facing FDA in seeking to understand the real-world use of opioids to treat pain, including the impact of opioids with potentially less risk for abuse; (4) the role that FDA plays as a part of a larger Federal, State and local response to the challenges of providing appropriate pain treatment while reducing opioid abuse; and (5) postmarket surveillance activities related to opioids. The Science Board will also receive a final report from the Centers of Excellence in Regulatory Science and Innovation (CERSI) Program Evaluation Subcommittee. More information

Patient and Medical Professional Perspectives on the Return of Genetic Test Results Workshop (Mar 2)

FDA is announcing the following public workshop titled “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.” The purpose of this workshop is to understand patient and provider perspectives on receiving genetic test results. The topic(s) to be discussed will focus on better defining the specific information patients and providers prefer to receive, how those results should be returned, and what information is needed to understand the results so that they may effectively aid in medical decision making. More information

Vaccines and Related Biological Products Advisory Committee (Mar 4)

The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season. More information

Primary Sclerosing Cholangitis (PSC) Workshop with the FDA, AASLD, ACG, AGA and NASPGHAN (Mar 3-4)

This workshop will provide a forum for discussion of issues related to PSC by academic specialists and researchers, industry, the FDA, representatives from the European Medical Authority (EMA) and other international regulatory agencies, and the patient community. The workshop will provide presentations and discussions on what is known about PSC, the definition, natural history and current therapeutic interventions for PSC, also presentations and additional discussions of potential trial designs and endpoints, including surrogate endpoints for clinical trials intended to support marketing applications for drugs to treat PSC in both adults and children. More information

Pharmacy Compounding Advisory Committee Meeting (Mar 8-9)

On March 8, 2016, the committee will discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA will discuss the following nominated bulk drug substances: quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. The nominators of these substances will be invited to make a short presentation supporting the nomination. More information

Circulatory System Devices Panel of the Medical Devices Advisory Committee (Mar 15-16)

On March 15, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System sponsored by Abbott Vascular. On March 16, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AngelMed Guardian System sponsored by Angel Medical Systems, Inc. More information

NEW DATE - Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy Workshop (Mar 18)

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. The goal of the workshop is to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness. More information

2016 DILI Conference XVI: How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials? (Mar 23-24)

The purpose of this scientific workshop is to discuss ways in which to measure, evaluate and act upon liver injury and dysfunction caused by drugs in clinical trials. The primary audience includes leading academic experts, interested pharmaceutical companies, regulatory agencies, patient advocacy groups, non-profit organizations, scientists, clinicians from regulatory, academic, industrial and other healthcare sectors, scientists involved in drug development in those same industries,  pharmacokineticists (clinical, preclinical, and toxicokinetics) who are involved in qualification of safety biomarkers or directly impacted by the qualification of safety biomarkers for drug development. More information

Psychopharmacologic Drugs Advisory Committee (Mar 29)

The committee will discuss the specific risk-benefit profile for new drug application (NDA) 207318, NUPLAZID (pimavanserin) 17 milligram (mg) immediate-release, film-coated oral tablets, submitted by Acadia Pharmaceuticals Inc., for the proposed treatment of psychosis associated with Parkinson's disease. More information

Gastrointestinal Drugs Advisory Committee Meeting (Apr 7)

The committee will discuss new drug application (NDA) 207999, obeticholic acid oral tablets, submitted by Intercept Pharmaceuticals, Inc., proposed for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. More information 

Oncologic Drugs Advisory Committee Meeting (Apr 12)

The committee will discuss new drug application (NDA) 208542 rociletinib tablets, application submitted by Clovis Oncology, Inc. The proposed indication (use) for this product is for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test. More information

Pediatric Advisory Committee Meeting (Apr 12)

On Tuesday, April 12, 2016, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for FLULAVAL QUADRIVALENT (Influenza Virus Vaccine), FLULAVAL TRIVALENT (Influenza Virus Vaccine),FLUZONE QUADRIVALENT (Influenza Virus Vaccine). ACIPHEX SPRINKLES (rabeprazole sodium), MYCAMINE (micafungin sodium), NOXAFIL (posaconazole), PRECEDEX (dexmedetomidine hydrocholoride), SABRIL (vigabatrim), SEROQUEL (quetiapine fumarate) & SEROQUEL XR (quetiapine fumarate extended- release), SKYLA (levonorgestrel-releasing intrauterine system), SYMBAX (fluoxetine hydrocholoride and olanzapine), VYVANSE CAPSULES (lisdexamfetamine dimesylate), and XELODA (capecitabine). More information

Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies (Apr 13-14)

FDA is announcing its fifth public workshop on Computer Methods for Medical Devices entitled “FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices.” More information

Nonprescription Drugs Advisory Committee Meeting (Apr 15)

The committee will discuss data submitted by Galderma Laboratories, L.P. to support supplemental new drug application (sNDA) 20-380, for over-the-counter (OTC) marketing of adapalene gel 0.1%. The proposed OTC use is for the treatment of acne and to clear up acne pimples and acne blemishes. The applicant proposes to label the product for 12 years and older. The committee will be asked to consider whether data support an acceptable risk/benefit profile for the nonprescription use of adapalene gel 0.1% by OTC consumers. 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