FDA Updates for Health Professionals

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

ANNOUNCEMENTS

FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. More information

FDA proposes ban on most powdered medical gloves

FDA announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.

The proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove. More information

Continuing Education Opportunity- FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond

The purpose of this continuing education (CE) course is to educate a national audience of health care providers, industry, and consumers about the basics of the FDA drug regulatory process and the science that supports CDER’s mission. The course will also educate the nation’s health care providers about their role in communicating drug information to their patients.  Free accredited CE for physicians, nurses, nurse practitioners, physician assistants, and pharmacists. More information

A ‘Roadmap’ for Navigating Patient Advocacy

FDA’s Center for Drug Evaluation and Research (CDER) is sponsoring a daylong public workshop on March 31, 2016, titled "Navigating CDER: What You Should Know for Effective Engagement". Our presentations will help patient advocates gain a better understanding of FDA and provide specific resources to help you and your colleagues learn ways to effectively advocate and engage with the Agency on behalf of the patients you serve. More information

FDA Unveils Multilingual Health Fraud Protection Initiative for Consumers Consumers are constantly bombarded by advertisements for fraudulent medical treatments and cures — dangerous scams that often target the most vulnerable populations. FDA is fighting back with its own enhanced educational initiative. And we’re urging health professionals and community leaders to help. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

NIH and FDA Request for Public Comment on Draft Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies The National Institutes of Health (NIH) and Food and Drug Administration (FDA) are developing a template with instructional and sample text for NIH funded investigators to use in writing protocols for phase 2 or 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications.  The agencies’ goal is to encourage and make it easier for investigators to prepare protocols that are consistently organized and contain all the information necessary for the clinical trial to be properly reviewed.  The draft template follows the International Conference on Harmonisation (ICH) E6 Good Clinical Practice.  More information

Sunlamp Products; Proposed Amendment to Performance Standard

FDA is proposing to amend the performance standard for sunlamp products and ultraviolet (UV) lamps intended for use in these products. This standard was last amended in 1985. The current amendments seek to improve consumer safety by requiring more effective communication regarding the risks posed by these products. They also would reduce risks to consumers by updating technical requirements to reflect current science, and by adopting and incorporating by reference certain elements from the International Electrotechnical Commission (IEC) International Standard 60335-2-27, Ed. 5.0: 2009-12. More information

PRODUCT APPROVALS & CLEARANCES

FDA expands use of Xalkori to treat rare form of advanced non-small cell lung cancer FDA approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. More information

FDA approves new treatment for inhalation anthrax

FDA approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. More information

FDA approves new psoriasis drug Taltz

FDA approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. More information

FDA approves Cinqair to treat severe asthma

FDA approved Cinqair (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines. 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.

Recall: Amikacin Sulfate Injection USP, 1 gram/4mL (250 mg/mL) Vials by Teva - Glass Particulate Matter Teva Pharmaceuticals announced a voluntary recall of one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of particulate matter identified as glass in one vial. The recalled lot # is 4750915, Expiration Date 9/2017.More information Class I Recall: Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex - Sheath Body may become Separated from Sheath Hub Teleflex Incorporated announces worldwide recall of Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits. More information FDA Statement: Eye Drops - Potential Risk of Loose Safety Seals FDA is warning the public about eye drop bottles that have loose plastic safety seals or tamper evident rings below the bottle cap that may fall onto the eye when the product is used. More information

February 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

Safety Communication: Duodenoscope Models TJF-160F and TJF-160VF by Olympus - Reprocessing Instructions Validated

Olympus Corporation of the Americas (Olympus) has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160VF duodenoscope models (160 F/VF duodenoscope models) to replace those provided in the original device labeling. The FDA reviewed the updated reprocessing instructions and the validation data and determined that they meet the Agency's expectations. More information

FDA Alert: Human and Animal Sterile Drug Products by I.V. Specialty - Lack of Sterility Assurance

The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by I.V. Specialty Ltd., Austin, Texas, due to lack of sterility assurance. On March 7, 2016, FDA recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile.  The company has neither ceased sterile production nor initiated a recall. Therefore, FDA is alerting health care professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty.More information

Opioid Pain Medicines: Drug Safety Communication - New Safety Warnings Added to Prescription Opioid Medications

FDA is warning about several safety issues with the entire class of opioid pain medicines. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks. More information

Sodium Bicarbonate Injection, USP by Hospira: Recall - Particulate Matter

Hospira, Inc. is recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry 1AUG2017) at the hospital/retail level due to the presence of a particulate within a single–dose glass fliptop vial. The issue was identified through a confirmed complaint. More information

GlideScope Titanium Single-Use Video Laryngoscope by Verathon: Class I Recall - Potential Video Feed Disruption

Verathon Incorporated is recalling the GlideScope Titanium Single-Use Video Laryngoscope because of a potential disruption in the video feed from the camera in the laryngoscope blades to the monitor. A disrupted or unstable video image may lead to delayed tracheal tube insertion, intubation failure and other serious adverse health consequences, including low levels of oxygen in the blood (hypoxemia), end organ damage or death. 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.

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

Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop (Apr 14-15)

FDA's Center for Drug Evaluation and Research, in co-sponsorship with the Foundation for the National Institutes of Health Biomarkers Consortium, is announcing a public meeting entitledDeveloping an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop. 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

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (Apr 20)

The Committee will discuss, make recommendations, and vote on the premarket approval application for the Cartiva Synthetic Cartilage Implant (SCI), sponsored by Cartiva, Inc.  The Cartiva Synthetic Cartilage Implant (SCI) is an organic polymer-based biomaterial to mimic biologic cartilage.  The device is to be indicated for treatment of degenerative and post-traumatic arthritis in the first metatarsophalangeal joint in the presence of good bone stock along with the following clinical conditions:  hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsophalangeal joint. More information

Public Workshop - Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids (Apr 21)

FDA) is announcing the following public workshop titled "Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids."  The topic to be discussed is the appropriate level of Good Manufacturing Practices (GMPs) regulation to ensure the safety and effectiveness of air-conduction hearing aid devices. More information

Public Meeting: Childhood Cancer Advocacy Forum 2016 (Apr 22)

Update of cancer drugs approved for pediatric use, BPCA/WR study results which have informed product labeling, PREA and iPSPs for oncology drugs- impact on issuance of WRs, Expanding patient-focused drug development to children with cancer and Pediatric PROs, Expanded Access to investigational drugs, Expanding Eligibility Criteria for clinical trials to accommodate early evaluation of certain products in children, and promising new Vaccine and Engineered Cell Products for cancer.More information

Peripheral and Central Nervous System Drugs Advisory Committee (Apr 25)

The committee will discuss new drug application (NDA) 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. More information

Evaluation of the Safety of Drugs and Biological Products used during Lactation (Apr 27-28)

FDA’s Division of Pediatric and Maternal Health in CDER, is announcing a 2-day public workshop, “Evaluation of the Safety of Drugs and Biological Products used during Lactation”. The purpose of this 2-day workshop is to provide a forum to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. More information

Public Workshop - Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices (May 2)

FDA) is announcing a public workshop entitled “Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.” The topics to be discussed are the specific analytical and clinical study designs and considerations for validation and use of liquid chromatography/mass-spectrometry (LC/MS)-based in vitro diagnostic devices (IVDs) in the clinical laboratory. The primary focus will be on the validation considerations with protein- and peptide-based LC/MS devices. More information

Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee (May 3-4)

On May 3 and 4, 2016, the committees will discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The Agency will seek the committees' comments as to whether this REMS with ETASU assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system.More information

Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee (May 5)

The committees will be asked to discuss new drug application (NDA) 208653, benzhydrocodone/acetaminophen oral tablets, submitted by KemPharm, Inc., with the proposed indication of short-term (up to 14 days) management of acute pain. The product has been formulated with the intent to provide abuse-deterrent properties. More information

FY 2016 Regulatory Science Initiatives Part 15 Public Meeting (May 20)

FDA will hold a public meeting that will provide an overview of the current status of the regulatory science initiatives for generic drugs and will provide an opportunity for public input on research priorities in these topic areas. More information

Endocrinologic and Metabolic Drugs Advisory Committee (May 24)

The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. More information

Endocrinologic and Metabolic Drugs Advisory Committee (May 25)

The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus. 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