FDA Updates for Health Professionals

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

ANNOUNCEMENTS

FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens FDA is expanding its award-winning “The Real Cost” campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time, messages on the dangers of smokeless tobacco use – including nicotine addiction, gum disease, tooth loss, and multiple kinds of cancer – are being highlighted through the placement of advertisements in 35 U.S. markets specifically selected to reach the campaign’s target audience. “The Real Cost” extension draws attention to harmful rite of passage for many at-risk teenagers. More information

What We Mean When We Talk About EvGen  - Part I: Laying the Foundation for a National System for Evidence Generation

In the first blog of this multi-part series, Rachel E. Sherman, M.D., M.P.H., Associate Deputy Commissioner for Medical Products and Tobacco and Robert M. Califf, M.D., Commissioner of the U.S. Food and Drug Administration, look at the elements required to build such a national system, beginning with a pair of foundational concepts—interoperability and connectivity. More information

2015: An Important Year for Advancing Generic Drugs at FDA

FDA's Office of Generic Drugs (OGD) is committed to holding the generic drug industry to standards of high quality, and to maintaining the public’s confidence that generic drugs are safe, effective, affordable alternatives to brand name drugs. Kathleen “Cook” Uhl, M.D., Director of the Office of Generic Drugs in the Center for Drug Evaluation and Research discusses how the generic drugs allow greater access to health care for all Americans and highlights OGD's 2015 Annual Report, which provides a summary of first-time generic drug approvals in 2015 and other activities supporting the generic drug industry and patient interests. More information

CDER Conversation on the Breakthrough Therapy Designation In this two part interview, Dr. Moscicki takes a deep dive into FDA’s Breakthrough Therapy designation to help clarify common misunderstandings around this expedited program, and breaks down each of CDER’s expedited pathways to help readers understand not only the lingo, but also the implications of expedited reviews and approvals.More information

Continuous Manufacturing Has a Strong Impact on Drug Quality

For decades, most drugs have been manufactured using what is known as “batch” technology — a process whereby the ultimate finished product has been made after many stops and starts in a series of steps. Unfortunately each break in the process causes inefficiency and delay, as well as the increased possibility of defects and error. Lawrence Yu, Ph.D., FDA’s Deputy Director from the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, discusses how a new technology - continuous manufacturing - enables much faster production and more reliable products through an uninterrupted process. More information

FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns

FDA took the first step toward rescinding its approval of the use of carbadox to treat swine because the drug may leave trace amounts of a carcinogenic residue. The Center for Veterinary Medicine (CVM)'s action comes after the center recently reexamined the safety profile of the drug and conducted a preliminary risk characterization that indicated there could be potential risk to human health from ingesting pork, especially pork liver, derived from carbadox-treated pigs.The FDA is not recommending that people make changes in their food choices while the agency is working to remove carbadox from the market. Potential cancer risks are based on an assumed lifetime of consuming pork liver or other pork products containing carbadox residues, and short-term changes in diet are unlikely to affect a person's lifetime risk. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

FDA issues three new draft guidances related to compounding of human drugs FDA issued three draft guidance documents related to human drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by Title I of the Drug Quality and Security Act (DQSA) in November 2013, that apply to both outsourcing facilities and compounders seeking to operate under section 503A.The draft guidance documents describe FDA’s proposed policies concerning: the prescription requirement in section 503A of the FD&C Act, how the agency intends to apply the prescription requirement in section 503A to compounding in a hospital or health system pharmacy, and the definition of the term “facility” in section 503B of the FD&C Act.  More information

Draft Guidance on Safety Considerations for Product Design to Minimize Medication Errors

This guidance provides a set of principles for using a systems approach to minimize medication errors relating to product design and container closure design and thus enhance patient safety. The recommendations in this guidance document are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drugs and biologic products regulated by the Center for Drug Evaluation and Research (CDER), which are referred to collectively in this guidance as products. The guidance also provides examples of product designs that have resulted in postmarketing medication errors. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves first leadless pacemaker to treat heart rhythm disorders FDA approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart. More information

FDA approves folic acid fortification of corn masa flour

FDA approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of certain other enriched cereal grains. Folic acid, a synthetic form of folate, is a B vitamin that when taken by a pregnant woman may help prevent neural tube defects, which are birth defects affecting the brain, spine, and spinal cord. Pregnant women with folate deficiency have a higher risk of giving birth to infants affected with neural tube defects. More information

FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality

FDA approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venclexta is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with CLL. More information

FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients

FDA permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the device is an effective tissue containment system, the FDA is requiring the manufacturer to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures. 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.

Class I Recall: G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers by Dexcom - Audible Alarm Failure Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when hypoglycemia or hyperglycemia are detected. Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low or high blood sugar. More information

CDER Statement: Sterile Drug Products from Pharmakon Pharmaceuticals, Inc - Lack of Sterility Assurance and Other Quality Issues

FDA is alerting health care professionals not to use any drug products that are intended to be sterile which are produced and distributed nationwide by Pharmakon Pharmaceuticals Inc., due to a lack of sterility assurance and other quality issues. Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Pharmakon, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. More information

Recall: Fetch 2 Aspiration Catheter by Boston Scientific - Shaft Breakage

Boston Scientific has initiated a voluntary recall of all models of its Fetch 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled due to complaints of shaft breakage. All affected healthcare facilities were advised to discontinue use of all Fetch 2 catheters immediately and return unused product to Boston Scientific. More information

Recall: 50 Percent Magnesium Sulfate Injection, USP by Hospira - Presence Of Particulate Matter

Hospira, Inc. is voluntarily recalling one lot of 50% Magnesium Sulfate Injection, USP, 10 g/20 mL (0.5 g/ml), 20 mL Single-dose vials, to the hospital level due to a confirmed customer complaint for the presence of particulate matter, within one single-dose fliptop vial. A recall was previously executed for this lot due to a confirmed high out of specification (OOS) result for pH. If the particulate is not observed prior to administration, it may result in localized swelling, redness, pain at the site of administration or veins, allergic reactions to the foreign particle, microembolic effects as well as possible fetal harm. The likelihood of serious patient harm is considered low due to high-detectability of this non-conformance. More information

Class I Recall: Focus Diagnostics Laboratory Examination Kits - Inaccurate Test Results

Focus Diagnostics is recalling Simplexa Herpes Simplex Virus 1 & 2 Direct and Simplexa Group A Strep Direct kits containing the Direct Amplification Discs due to poor lamination between the sample reaction wells. This poor lamination may lead to leakage into adjacent wells causing cross-contamination between samples, which could yield false positive, false negative, or invalid test results. Inaccurate diagnostic test results may lead to improper patient treatment for HSV or GAS and may cause serious adverse health consequences, including death. More information

Recall: Super Herbs Capsules - Undeclared Drug Ingredients

Super Herbs is voluntarily recalling all bottles of SUPER HERBS, light green and dark green capsules to the consumer level after FDA laboratory testing found SUPER HERBS to contain sibutramine, desmethylsibutramine, and/or phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market. Desmethylsibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolpthalein was previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is no longer marketed in the U.S. More information

Class I Recall: Guardian II Hemostasis Valves by Vascular Solutions, Inc. - Risk of Air Leakage

Vascular Solutions, Inc. initiated a nationwide recall of Guardian II hemostasis valves used in catheterization procedures. The recalled products are specific lots of Model Numbers 8210 and 8211. The products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. Healthcare facilities that have the affected Guardian II hemostasis valves should remove the products from their inventory and return them to Vascular Solutions. More information

Drug Safety Communication: Metformin-containing Drugs - Revised Warnings for Certain Patients With Reduced Kidney Function

FDA requiring changes to metformin labeling to provide specific recommendations on use in patients with mild to moderate kidney impairment. FDA has concluded, from the review of studies published in the medical literature, that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. FDA is requiring changes to the metformin labeling to reflect this new information and provide specific recommendations on the drug’s use in patients with mild to moderate kidney impairment. More information

March 2016 Drug Safety Labeling Changes

Pharmacists in the Office of Health and Constituent Affairs reviewed March 2016 labeling changes to inform you of 35 products with safety revisions to prescribing information  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.

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

Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation Workshop (May 19)

FDA will hold a public workshop titled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation”. Modeling and simulation tools help with developing bioequivalence and regulatory evaluation for oral drug products. 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