As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs wants to make you aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the topics with a brief summary and links to detailed information on the FDA Web site.

December 3, 2014

Pregnancy and Lactation Labeling Final Rule Issued Today  The Pregnancy and Lactation Labeling Rule (PLLR or final rule) requires changes to the content and format for information presented in prescription drug labeling in the Physician Labeling Rule (PLR) format to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thus allowing them to make informed and educated decisions for themselves and their children. The PLLR removes pregnancy letter categories – A, B, C, D and X. The PLLR also requires the label to be updated when information becomes outdated. More information

PRODUCT SAFETY

Need Safety Information? For more important safety information on human drugs, medical devices, dietary supplements and more, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here. Problem With a Medical Product?  Tell FDA about problems with human drugs, medical devices and more using the MedWatch Online Voluntary Reporting Form

Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall - Potential Mold Contamination Recall Classified as Class I. Since Philips Healthcare’s May 2014 recall, the firm has received 12 new complaints of visible mold on their devices, including one injury. More information

Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels: Class I Recall - May Produce Incorrect Results

Incorrect test results may occur for the following antibiotics: Aztreonam, Cefotaxime, Ceftazidime, and Ceftriaxone. More information 

CONMED PadPro and R2 Multi-function Defibrillation Electrodes: Device Correction - Connector Compatibility Issue With Philips FR3 and FRx Defibrillator Units

These electrodes will not connect with Philips FR3 or FRx AED units.This may result in a delay in therapy. More information

Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported

FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died.  More information

Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication - Use Discouraged Due to Increased Risk in Women With Uterine Fibroids

FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications.More information 

Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Recall - Complaints of Empty Capsules

Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules. More information 

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

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

PRODUCT APPROVALS & CLEARANCES

FDA approves IDEAL IMPLANT Saline-filled Breast Implant - P120011

The IDEAL IMPLANT Saline-filled Breast Implant consists of multiple silicone shells within an outer shell. It has two valves that fill the device with saline. The IDEAL IMPLANT Saline-filled Breast Implant is available in a variety of sizes. More information

FDA allows marketing of non-invasive device to help evaluate heart blood flow

FDA allowed marketing of the HeartFlow FFR-CT software, which permits health care professionals to non-invasively evaluate blood flow in the coronary arteries of patients showing signs and symptoms of coronary artery disease.  More information  

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

OPPORTUNITIES FOR COMMENT / GUIDANCES

Infusion Pumps Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff; Availability The recommendations in this guidance are intended to improve the safety and effectiveness of these devices. This guidance also describes considerations in preparing premarket submissions for infusion pumps and identifies device features that manufacturers should address throughout the total product life cycle. More information

Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads

This project will examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in direct-to-consumer (DTC) prescription drug ads. Submit either electronic or written comments on the collection of information by January 12, 2015.More information

Spousal Influence on Consumer Understanding of and Response to Direct-To-Consumer Prescription Drug Advertisements

This study will examine differences between consumers viewing prescription drug ads with a spouse or partner versus alone through empirical research.Submit either electronic or written comments on the collection of information by January 13, 2015. More information

Comment Request: Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products

The term “modified risk tobacco product” means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Submit comments by January 20, 2015.  More information

New Clinical Trials Demographic Data; Availability for Comment

FDA is announcing the availability for public comment of Demographic Subgroup Data for FDA Approved Products on FDA's Internet Web site. This new posting implements Action 3.1 from Priority 3 of the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan designed to improve the availability and transparency of clinical trial demographic subgroup data. FDA is requesting comments on the format, content, and overall usability of the site to determine whether this approach is user friendly to the public. Submit electronic or written comments on the content byJanuary 23, 2015. More information 

ANNOUNCEMENTS

Targeting Drugs for Rare Diseases-Featuring Gayatri R. Rao, MD, JD, Director, Office of Orphan Products Development, FDA Increasingly in the routine practice of medicine, we are seeing more patients with rare diseases. Part of the reason for that is an increase in the diagnosis of rare diseases. Before, we would cluster groups of patients into syndromes, and now we are realizing that there are actually different disease states. More information

FDA issues additional guidance for outsourcing facilities that compound sterile human drugs FDA  issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act(DQSA), which was enacted in November 2013. More information

From our perspective: Clinical biomarker qualification

Biomarkers can be employed in many different aspects of drug discovery and development and also in the health care setting. Biomarker research can increase our understanding of the molecular underpinnings of a disease process, and this in turn can result in discovery of novel drug targets. More information 

CDER Conversations: Drug trials snapshots 

FDA released an “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.” One priority stated in the report is to make demographic data from clinical trials more available and transparent. To reach this goal, FDA’s Center for Drug Evaluation and Research is releasing drug trials snapshots that outline the participation of people in clinical trials by sex, race and age. The drug trial snapshots highlight information in an easy-to-read format. More information

FDA finalizes menu and vending machine calorie labeling rules FDA  finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants, similar retail food establishments and vending machines with 20 or more locations to provide consumers with more nutritional information about the foods they eat outside of the home. The rules are required by the 2010 Patient Protection and Affordable Care Act.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.

Anti-Infective Drugs Advisory Committee (December 4)

The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options. More information

Electronic Cigarettes and the Public Health - Public Workshop (December 10-11)

The workshop will include presentations and panel discussions about the current state of the science, and will focus on product science, packaging, constituent labeling, and environmental impacts. FDA intends to follow this workshop with two additional electronic cigarette workshops, with one on individual health effects and one on population health effects. More information

Pediatric Oncologic Subcommittee of the Oncologic Drugs Advisory Committee (December 11)

Information will be presented to gauge investigator interest in exploring potential pediatric development plans for three products in various stages of development for adult cancer indications. More information

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (December 12)

The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated.More information

Food Advisory Committee Meeting (December 16-17)

The committee will discuss science issues surrounding susceptible life stages or populations and the circumstances under which FDA might decide to conduct a separate risk assessment for these populations. Also, FDA is requesting advice from the Food Advisory Committee on how to integrate concern for susceptible populations into its risk assessment procedures and methodologies including under what conditions a separate risk assessment should be conducted. More information

Framework for Regulatory Oversight of Laboratory Developed Tests; Public Workshop; Request for Comments (Jan 8 & 9)

The purpose of this workshop is to discuss FDA's proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs), which are intended for clinical use and designed, manufactured and used within a single laboratory, and provide an additional opportunity for public comment. More information

Anti-Infective Drugs Advisory Committee Meeting (Jan 22)

The committee will discuss new drug applications (NDAs) 207-500 and 207-501, isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, sponsored by Astellas Pharma Global Development, Inc., respectively for the proposed indications of treatment of invasive aspergillosis and mucormycosis.