FDA Updates for Health Professionals

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

ANNOUNCEMENTS

Whole Genome Sequencing: Cracking the Genetic Code for Foodborne Illness A person commits a crime, and the detective uses DNA evidence collected from the crime scene to track the criminal down. An outbreak of foodborne illness makes people sick, and the FDA uses DNA evidence to track down the bacteria that caused it. Sound far-fetched? It’s not. The FDA has increasingly used a complex, cutting-edge technology called whole genome sequencing to support investigations of foodborne illnesses. More information

FDA Announces the New Acting Director of the FDA Oncology Center of Excellence

The FDA is honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative (“Cancer Moonshot”), which calls on the agency to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices to create the Oncology Center of Excellence (OCE). The OCE will expedite the development of novel combination products and support an integrated approach to tackle this devastating disease that touches so many American families. More information

Sleuthing, and a Little Help from Consumers, Helps FDA Track Down Bacteria in Flour

The story of the recent recall of 10 million pounds of baking and cooking flour is one in which federal agencies, consumers and General Mills – all had a role in doggedly tracking down the source of an outbreak that has made dozens of people across the country sick and getting the suspect product off the market. More information

FDA Celebrates the 40th Anniversary of the Medical Device Amendments

In 1976, Steve Jobs and Steve Wozniak founded Apple and a gallon of gas was $.59. And in another action that has had long term impact, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age problems." The law ushered in a new era for medical technology innovation, patient access, and patient safety, but also created a tension, contributing to a political environment where the pendulum continues to swing between these objectives, defining and driving the medical device ecosystem ever since. More information

FDA: A Great Place for Science…and for Scientists on the New Frontier of Regulatory Science Whether you’re a biologist, chemist, epidemiologist, pharmacist, statistician, veterinarian, nurse, physician, or an engineer and whether you’re a recent graduate or a seasoned scientist, FDA offers an unmatched opportunity to be a part of a vibrant, collaborative culture of regulatory science. As one FDA scientist commented, “At FDA, your work is really at the crossroads of cutting-edge technology, patient care, tough scientific questions, and regulatory science.” More information

Important Steps Toward Streamlining Access to Investigational Drugs for Patients in Need

FDA is only too aware that there are many patients who have a serious or life-threatening medical condition for which there is no available FDA-approved therapy. For such patients, one option may be to obtain access to an investigational drug that has not yet been approved by FDA. To do this, a physician submits an application to the FDA requesting authorization to use the investigational drug in the treatment of their patient. This is called expanded access to investigational drugs. More information

FDA, in Collaboration with AMA, Releases Continuing Medical Education Video about the Nutrition Facts Label

FDA in collaboration with the American Medical Association (AMA), announced a continuing medical education (CME) video for physicians about using the Nutrition Facts Label (NFL) to help patients make healthful eating choices. The video is designed to educate physicians about the NFL, give practical strategies for discussing nutrition with their patients, and better equip them to offer guidance that is important for general health, combating obesity, and reducing the risk of other chronic illnesses, such as cardiovascular disease. More information

FDA Drug Info Rounds Video Need a quick tutorial on FDA’s improved REMS database?  Check out FDA’s new REMS@FDA video. In less than 3 minutes, FDA pharmacists show you how to navigate FDA’s user-friendly REMS website. The new website makes it easier than ever to see what is required to prescribe or dispense a drug with a REMS. More information

DDI Webinar Series: An Overview of FDA's Expanded Access Process and the New Individual Patient Expanded Access Application - July 12, 2016 1-2 pm EST

This DDI webinar will discuss and summarize the purpose of FDA’s expanded access program, including the types of expanded access requests accepted by FDA, the requirements for requesting individual expanded access and the costs physicians may charge patients for single patient expanded access.  The speakers will review and explain how to submit single patient IND expanded access requests to the FDA using the new FDA Form 3926. To register for the online meeting, please visit:https://collaboration.fda.gov/ddi071216/event/registration.html  

The Generic Drug Approval Process

Generic drugs are copies of innovator or brand-name prescription drugs and make up about 88 percent of prescriptions filled in the United States. Brand-name drugs must demonstrate their safety and effectiveness through expensive and time-consuming research and development programs, including clinical studies. In contrast, generic drug developers can use data from their brand-name counterparts, resulting in much less expensive development programs and affordable access to treatments for many patients and consumers. More information

Consumer Update: Coping With Memory Loss Everyone has mild memory lapses from time to time. You can’t find your car keys one day, and your reading glasses go missing the next. These are usually just signs of a normal brain that’s constantly prioritizing, sorting, storing, and retrieving all types of information. But how do you know when memory loss is abnormal – and should be evaluated by a health care professional? More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing This final guidance allows manufacturers to use the ISO 10993-1 standard when assessing the potential biological response of the medical devices and materials that come into direct or indirect contact with the human body. More information

Draft Guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

The purpose of this guidance is to clarify how the FDA assesses benefits and risks for medical devices already available on the market. The draft guidance focuses on the factors the FDA may consider when making decisions related to compliance and enforcement actions for a specific medical device company, or when making decisions that may affect a medical device’s availability on the market. In addition to evaluating scientific and clinical data, the FDA may also consider the patient perspective and other real-world data when determining a device’s safety profile. More information

Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act

These guidance documents explain FDA’s policy regarding the conditions under which the agency does not intend to take action against state-licensed pharmacies, federal facilities, and licensed physicians (under section 503A) or outsourcing facilities (under section 503B) that compound drug products from bulk drug substances that cannot otherwise be used in compounding under these sections. More information

FDA requests additional information to address data gaps for consumer hand sanitizers

FDA issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in consumer antiseptic rubs (hand sanitizers) marketed over-the-counter (OTC). The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean the FDA believes these products are ineffective or unsafe. The proposed rule does not require any consumer hand sanitizer products to be removed from the market at this time. Instead, it requires manufacturers who want to continue marketing these products under the OTC Drug Review to provide the FDA with additional data on the active ingredients’ safety and effectiveness, including data to evaluate absorption. More information

Use of Symbols in Labeling

FDA  is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as “stand-alone symbols”) if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. More information

Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition Draft Guidance: Dissemination of Patient-Specific Information from Devices by Device Manufacturers 

The purpose of this guidance is to clarify that that FDA requirements do not prohibit manufacturers from sharing patient-specific information recorded, stored, processed, retrieved and/or derived from a medical device with the patient who is either treated or diagnosed with that device.  We hope that clarification of this policy will help patients receive access to accurate, usable information from medical devices so that they can be more engaged with their healthcare providers in making sound medical decisions. More information

Labeling for Biosimilar Products; Draft Guidance for Industry; Availability; Extension of Comment Period

FDA is extending the comment period for the notice that published on April 4, 2016 (81 FR 19194) by an additional 60 days. Although you can comment on any guidance at any time to permit the Agency to consider your comments before issuing the final version of the guidance, submit either electronic or written comments on the draft guidance by August 2, 2016. More information

Draft Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods

FDA issued a  draft guidance for public comment that provides voluntary sodium reduction targets for the food industry. The draft short-term (2-year) targets seek to decrease sodium intake to about 3,000 mg per day. The long-term (10-year) targets seek to reduce sodium intake to 2,300 milligrams per day. The targets, which cover nearly 150 food categories, are intended to complement many existing efforts by food manufacturers, restaurants and food service operations to reduce sodium in foods.More information

FDA’s final guidance: “Postmarket Surveillance Under Section 522 of the Federal Food, Drug & Cosmetic Act”

Section 522 of the Federal, Food, Drug and Cosmetic Act (the Act) provides the FDA with the authority to require device manufacturers to conduct postmarket surveillance of certain class II or class III devices.  This guidance document clarifies the 522 postmarket surveillance process and provides manufacturers with information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance plan submissions.More information

Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition

This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods. The responses to these FAQs address common questions about the definition of and regulations for medical foods. This guidance is a second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.” This guidance provides responses to additional questions regarding the definition and labeling of medical foods and updates some of the prior responses. More information 

PRODUCT APPROVALS & CLEARANCES

FDA approves Epclusa for treatment of chronic Hepatitis C virus infection FDA approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV. More information

FDA approves AspireAssist obesity device

FDA approved a new obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight. It is intended to assist in weight loss in patients aged 22 and older who are obese, with abody mass index of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy. 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 email subscribe here.

Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).  Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. 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.

Arthritis Advisory Committee Meeting (Jul 12 &13)

The committee will discuss biologics license application 761024, for ABP 501, a proposed biosimilar to AbbVie Inc.'s HUMIRA (adalimumab), submitted by Amgen, Inc.on July 12. The committee will discuss biologics license application 761042, for GP2015, a proposed biosimilar to Amgen Inc.’s ENBREL (etanercept) submitted by Sandoz, Inc.on July 13. More information

Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting  (Jul 19)

The committee will discuss biologics license application (BLA) 761032, brodalumab injection, a human monoclonal antibody, submitted by Valeant Pharmaceuticals Luxembourg S.à.r.l, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. More information

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting (Jul 21 & 22)

On July 21, 2016, the committee will discuss, make recommendations, and vote on information regarding a premarket approval application (PMA) panel-track supplement for a proposed change in intended use of Dexcom, Inc.’s, Dexcom G5® Mobile Continuous Glucose Monitoring System (CGM) device . On July 22, 2016, the committee will discuss and make recommendations on information regarding a premarket notification (510(k)) submission for the Alere Afinion™ HbA1c Dx point-of-care test system, sponsored by Alere Technologies AS.  The proposed intended use, as stated by the sponsor: More information

Cellular, Tissue, and Gene Therapies Advisory Committee Meeting (Jul 26)

On July 26, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Molecular Oncology and the Laboratory of Biological Chemistry, Division of Biotechnology Review and Research 1 and 4, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, FDA. More information  

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (Aug 10) 

The committee will discuss, make recommendations, and vote on information regarding a de novo request for the SEEKER Newborn Screening System (SEEKER System), by Baebies, Inc.  The SEEKER System consists of the SEEKER Analyzer, the SEEKER 4-Plex Assay Kit, the SEEKER Cartridges, the Spot Logic software, and quality control materials; it uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimens. More information

Pediatric Clinical Investigator Training; Public Workshop (Sept 12 & 13)

The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. More information

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee and the Pediatric Advisory Committee Meeting (Sept 15 & 16)

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation. 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

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  

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

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