UPDATES FOR HEALTH PROFESSIONALS

Office of Health and Constituent Affairs

ANNOUNCEMENTS

HIV and Hepatitis: Know Your Status and Learn About the FDA's Role

Health outcomes can be different among people of diverse ethnic and racial groups. These differences in health status are called health disparities. Health disparities exist for many diseases, including HIV/AIDS, hepatitis, diabetes, cancer, and heart disease. Racial and ethnic minorities may be more likely to have these diseases or may be more likely to have serious effects from them. More information

Redefining the Term “Healthy” on Food Packages – Public Process Plays a Crucial Role

When you see the word “healthy” used on a food package, what does that mean to you? It’s FDA’s job to make sure that terms like “healthy,” which many people rely on to make food choices for themselves and their families, are something that they can truly count on. And we’ve seen that the ability to include the claim “healthy” actually encourages food companies to produce healthier foods. More information

New FDA Drug Info Rounds Video: Definition of a Drug

Drug Info Rounds is brought to you by pharmacists in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Communications (OCOMM), Division of Drug Information (DDI). Pharmacists in DDI answer hundreds of questions everyday about drug products and FDA actions. Our goal is to provide important and timely drug information to pharmacists so they can help patients make better medication decisions. In the latest video, pharmacists discuss the key differences between the laws and regulations for drugs and cosmetics. Whether a product is regulated as a drug, a cosmetic, or both under the law is determined by a product's intended use. More information

Codeine and Tramadol Can Cause Breathing Problems for Children

Codeine and tramadol are opioid medicines that may be used to treat pain. Codeine is also in some cough and cold remedies. These medicines can cause life-threatening breathing problems in children. Some children and adults break down codeine and tramadol into their active forms faster than other people. That can cause the level of opioids in these people to rise too high and too quickly. Nursing mothers who are taking codeine or tramadol can pass unsafe levels of opioids to their babies through breast milk. Those infants can become too sleepy, have difficulty breastfeeding, or have serious breathing problems. More information

FDA and NIH Release Final Template for Clinical Trial Protocols

A little more than a year ago, FDA and NIH announced the availability of a draft template for investigators to use when organizing clinical trial protocols, which are essentially roadmaps for conducting a clinical trial. Today, we are excited to announce that the NIH-FDA Joint Leadership Council has issued a final version of the template, a development which is likely to contribute important efficiencies to the process of protocol development, saving medical product development time and money. More information

Working to Raise Awareness and Reduce Health Disparities

FDA’s Office of Minority Health (OMH) is committed to the HHS mission of advancing health equity, and our office works year-round to advance FDA’s message of ensuring the safety and efficacy of our nation’s food supply and medical products to all communities, but with a focus on minority groups. Today, minority communities and those at the lower socioeconomic rungs still remain disproportionately burdened by chronic disease and are much more likely to succumb to certain illnesses. More information

Improving the Safety of Imported Foods Through Partnerships

At FDA, we recognize that the partnerships we build with other nations are key to our success in giving American consumers confidence in the safety of the foods they choose to serve their families. FDA recently held a two-day public hearing in which we received input from domestic and international food safety experts on how we can build on these strategic partnerships. The safety of imported foods is of great interest to all of us and of utmost concern to the American public. About 15 percent of the U.S. food supply is imported, including nearly 50 percent of fresh fruit, 20 percent of fresh vegetables, and 80 percent of seafood. Those imports to the United States come from more than 200 countries and about 125,000 firms. More information

Products Claiming to "Cure" Cancer Are a Cruel Deception

Legitimate medical products such as drugs and devices intended to treat cancer must gain FDA approval or clearance before they are marketed and sold. The agency’s review process helps ensure that these products are safe and effective for their intended uses. Nevertheless, it’s always possible to find someone or some company hawking bogus cancer “treatments,” which come in many forms, including pills, capsules, powders, creams, teas, oils, and treatment kits. Frequently advertised as “natural” treatments and often falsely labeled as dietary supplements, such products may appear harmless, but may cause harm by delaying or interfering with proven, beneficial treatments. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Request for comment by May 19, 2017: Establishment of a Public Docket on Joint Meeting of the Pediatric Advisory Committee and the Pediatric Ethics Subcommittee

FDA announced a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) and the Pediatric Ethics Subcommittee (PES). On May 18, 2017, the PAC and the PES will meet to discuss a referral by an Institutional Review Board (IRB) of a clinical investigation that involves children and FDA regulated products. The clinical investigation is entitled “A Double-Blind, Placebo-Controlled, Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.” Comments about the upcoming joint meeting should be submitted to Docket No. FDA 2017-N-1780. More information

Enhancing Patient Engagement Efforts Across the Food and Drug Administration Request for Comments

FDA is establishing a public docket to solicit input on ongoing efforts to enhance mechanisms for patient engagement at the Agency. Engaging with patients, their caregivers, and advocates has long been a priority of the Agency. In this tradition, FDA intends to enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities. To achieve these goals, FDA is considering establishing a new Office of Patient Affairs. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves new combination treatment for acute myeloid leukemia

FDA approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML. More information

FDA approves first treatment for a form of Batten disease

FDA approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency. More information

FDA expands approved use of Stivarga to treat liver cancer

FDA expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer in almost a decade. More information

FDA approves Renflexis, Biosimilar to Remicade

FDA approved Renflexis (infliximab-abda) for multiple indications. Renflexis is administered by intravenous infusion. This is the second FDA-approved biosimilar to U.S.-licensed Remicade. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. More information

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

PRODUCT SAFETY

MedWatch, The FDA Safety Information and Adverse Event Reporting Program

For 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 email subscribe here.

Letter to Healthcare Providers: NavLock Tracker by Medtronic - Patient Injuries Reported

Medtronic issued a communication related to the use of non-Medtronic instruments with Medtronic's NavLock Tracker. This notice reports that Medtronic is aware of occurrences of minor and serious injuries, including two patient deaths, following procedures that involved the use of non-Medtronic instruments with Medtronic's NavLock Tracker. The two deaths noted involved patients undergoing a spinal procedure and experiencing post-operative hemorrhage. These two patient deaths occurred following a procedure that involved the use of 3rd party surgical stereotaxic navigation instruments that have not been cleared by the FDA for use with Medtronic’s NavLock Tracker on Medtronic’s StealthStation. More information

Drug Safety Communication: General Anesthetic and Sedation Drugs - FDA Approves Label Changes for Use in Young Children

FDA has approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. Changes include: a new warning stating that exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years; and additional information related to pregnancy and pediatric use to describe studies in animals that showed exposure to general anesthetic and sedation drugs for more than 3 hours can cause widespread loss of nerve cells in the developing brain resulting in long-term negative effects on the animals’ behavior or learning. More information

Recall: 25 Percent Dextrose Injection, USP (Infant) by Hospira - Particulate Matter

Hospira is voluntarily recalling one lot of 25% Dextrose Injection, USP, (Infant) pre-filled syringe to the hospital/user level due to the presence of particulate matter, identified as human hair, found within an internal sample syringe. If the particulate is administered to a patient, it could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or systemic allergic response to the particulate. Administration of the particulate could also result in localized phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, and pulmonary infarction. More information

Drug Safety Communication: Codeine and Tramadol Medicines - Restricting Use in Children, Recommending Against Use in Breastfeeding Women

FDA is restricting the use of codeine and tramadol medicines in children. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants. More information

FDA Warning: Illegal Cancer Treatments - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure

FDA issued warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses. More information

Recall: Organic Herbal Supply Supplement Products - Undeclared Drug Ingredients

Organic Herbal Supply, Inc. is conducting a voluntary nationwide recall of all lots of Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules. FDA analysis has found the products to contain Tadalafil, a FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The presence of tadalafil in these male enhancement products renders it an unapproved drug for which safety and efficacy have not been established. Organic Herbal Supply is also recalling Zrect for Women and LabidaMAX. FDA analysis has found these products contain Flibanserin, an FDA-approved prescription drug for Hypoactive Sexual Desire Disorder (HSDD) in women. 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.

Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Workshop (May 3)

The topics to be discussed will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders—industry, academia, patient advocates, professional societies, and other interested parties—as it fulfills its commitment under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing the fiscal year (FY) 2018 Regulatory Science Plan. More information

Public Meeting on Patient-Focused Drug Development for Autism (May 4)

On May 4, 2017, FDA is conducting a public meeting on Patient-Focused Drug Development (PFDD) for Autism. FDA is interested in obtaining patient perspectives on the impact of autism on daily life and patient views on treatment approaches. More information

Pharmacy Compounding Advisory Committee Meeting (May 8-9)

The committee will receive updates on certain issues to follow up on discussions from previous meetings, including quality standards and conditions at certain compounding facilities. In addition, the committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A Bulks List. FDA will discuss the following nominated bulk drug substances: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate, and artemisinin. The chart below describes which use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination. More information

Medical Imaging Drugs Advisory Committee Meeting (May 10)

The committee will discuss new drug application (NDA) 208-630 for 5-Aminolevulinic Acid Hydrochloride [5-ALA HCl], Powder, for oral solution, submitted by NX Development Corp., for the proposed indication as an imaging agent to facilitate the real time detection and visualization of malignant tissue during glioma surgery. More information

Oncologic Drugs Advisory Committee Meeting (May 24)

During the morning session, the committee will discuss new drug application (NDA) 208051, for neratinib maleate, an application submitted by Puma Biotechnology. The proposed indication (use) for this product is as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant traustuzumab-based therapy. During the afternoon session, the committee will discuss NDA 208587, for L-glutamine powder (oral solution), submitted by Emmaus Medical, Inc. The proposed indication (use) for this product is for the treatment of sickle cell disease. More information

Oncologic Drugs Advisory Committee (May 25)

The committee will discuss biologics license application (BLA) 125545, for a proposed biosimilar to Amgen Inc.ʼs Epogen/Procrit (epoetin alfa), submitted by Hospira Inc., a Pfizer company. The proposed indications/uses for this product are: (1) For the treatment of anemia due to chronic kidney disease, including patients on dialysis and not on dialysis, to decrease the need for red blood cell (RBC) transfusion; (2) for the treatment of anemia due to zidovudine administered at ≤ 4,200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ≤ 500 m units/mL; (3) for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppresive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy; and (4) to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to <13 a="" and="" are="" at="" blood="" data-saferedirecturl="https://www.google.com/url?hl=es&q=http://links.govdelivery.com:80/track?type%3Dclick%26enid%3DZWFzPTEmbWFpbGluZ2lkPTIwMTcwNTAzLjcyOTgzMTYxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDUwMy43Mjk4MzE2MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDExOTY5JmVtYWlsaWQ9Y2VyYXNhbGUzMTRAZ21haWwuY29tJnVzZXJpZD1jZXJhc2FsZTMxNEBnbWFpbC5jb20mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg%3D%3D%26%26%26130%26%26%26https://www.fda.gov/AdvisoryCommittees/Calendar/ucm553448.htm?source%3Dgovdelivery%26utm_medium%3Demail%26utm_source%3Dgovdelivery&source=gmail&ust=1494327028714000&usg=AFQjCNHuy7Don00g3sbIlMf2TuCV26JAtQ" dl="" elective="" for="" from="" g="" high="" href="http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwNTAzLjcyOTgzMTYxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDUwMy43Mjk4MzE2MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDExOTY5JmVtYWlsaWQ9Y2VyYXNhbGUzMTRAZ21haWwuY29tJnVzZXJpZD1jZXJhc2FsZTMxNEBnbWFpbC5jb20mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&130&&&https://www.fda.gov/AdvisoryCommittees/Calendar/ucm553448.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery" loss="" nbsp="" noncardiac="" nonvascular="" perioperative="" risk="" style="color: #1d5782;" surgery.="" target="_blank" who="">More information

DDI Webinar Series: Ongoing Role of FDA in Medication Error Prevention (Jun 6)

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. On June 6, 2017 at 1pm (EDT), CDER's Office of Communication, Division of Drug Information (DDI) will host a webinar titled: Ongoing Role of FDA in Medication Error Prevention. This free webinar will provide information on the Division of Medication Error Prevention and Analysis (DMEPA)’s role in preventing and addressing medication errors. Regulatory action taken to address recent medication error reports will be explored, as well as the role of pharmacists in identifying, preventing and mitigating medication errors. More information

Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting (Jun 15)

FDA's Center for Drug Evaluation and Research, Professional Affairs and Stakeholder Engagement Staff (PASES), is hosting a one day public symposium entitled “Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting.” The purpose of this symposium is to discuss sources of preventable harm from drugs in the outpatient setting, and to stimulate the exchange of ideas among thought leaders on interventions to reduce preventable harms and how these interventions can be studied. More information

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program

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 en druginfo@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

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

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