ANNOUNCEMENTS

Director's Corner Podcast: Working with Patient Advocacy Groups

The Director’s Corner is an audio podcast series featuring the director of FDA’s Center for Drug Evaluation and Research. In this podcast, Dr. Janet Woodcock discusses regulatory guidances drafted and submitted to FDA by patient advocacy groups. More information

Kicking off the PDUFA VI Reauthorization Process

The Prescription Drug User Fee Act (PDUFA) authorizes FDA to collect fees from pharmaceutical companies to help fund the agency’s drug review work. PDUFA’s intent is to provide additional funding for FDA to hire staff, improve systems, and establish a better-managed review process that enables us to do more timely reviews of human drug applications.

As a result, many important new drug therapies have been made available to patients sooner without compromising FDA’s high standards for safety, efficacy, and quality. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Draft Guidance - Rare Diseases: Common Issues in Drug Development

The FDA or Agency announced the availability of a draft guidance for industry entitled “Rare Diseases: Common Issues in Drug Development.” The purpose of this draft guidance is to advance and facilitate the development of drugs and biologics to treat rare diseases. Drug development for rare diseases has many challenges related to the nature of these diseases. This draft guidance is intended to assist sponsors of drug and biological products for treating rare diseases in conducting more efficient and successful development programs. More information

Medical Device Patient Labeling- Public Comments Requested

The CDRH Guidance on Medical Device Patient Labeling serves to assist manufacturers intheir development of patient labeling and to assist Center reviewers in their review and evaluation of the manufacturers' labeling. Medical device patient labeling includes any medical device information that is intended for a lay audience. It is intended to help assure that the device is used safely and effectively. This labeling may pertain to therapeutic, restorative, diagnostic, or cosmetic devices.More information

PRODUCT APPROVALS & CLEARANCES

FDA approves first treatment for sexual desire disorder

FDA approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner. More information

FDA extends use of Promacta in young children with rare blood disorder

FDA approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen. 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.

July 2015 Safety Labeling Changes

Pharmacists in the Office of Health and Constituent Affairs reviewed July 2015 product labeling changes to inform you of 49 products with safety revisions to prescribing information. More information

Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes

FDA is warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). FDA received reports of cases involving severe eye injuries and skin reactions associated with the application of Picato gel. Some cases were associated with Picato gel not being used according to the instructions for use on the label. As a result, FDA is requiring changes to the label to warn about these new safety risks and to provide additional instructions on the safe and appropriate application of the product. See the FDA Drug Safety Communication for additional information and recommendations. More information

Compounded and Repackaged Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Statement - Not to Use Unless There is No Suitable Alternative Available

FDA is alerting health care professionals not to administer to patients compounded or repackaged drugs that have been stored in 3 milliliter (ml) and 5ml syringes manufactured by Becton-Dickinson (BD) unless there is no suitable alternative available. Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe. More information

Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication - Quality Problems

FDA is alerting patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms. More information

OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company: Class I Recall - May Ignite and Burst

The company received reports that when the OxyTote is mishandled or dropped, the oxygen cylinder may ignite causing an internal flash fire and the canister to burst. More information

Prolotherapy with Phenol by Hartley Medical: Recall - Non-sterility Concerns

Hartley Medical is recalling three lots of Prolotherapy with Phenol, Injectable to the hospital/user level due to non-sterility concerns. This recall is a voluntary measure taken following a recent inspection with issues on Hartley's sterility methods and testing procedures specifically for this preparation. Parenteral administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or a fatal outcome. More information

Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall - Particulate Matter

Allergan announced that it is conducting a voluntary recall down to consumer level of specific lots of its Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh P.M. 3.5g for dry eye, FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g. 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.

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting (Sep 10)

The committees will be asked to discuss new drug application (NDA) 206830, oxycodone immediate-release tablets, submitted by Purdue Pharma, with the proposed indication of the management of moderate to severe pain where the use of an opioid analgesic is appropriate. More information

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting (Sep 11)

The committees will discuss new drug application (NDA) 208090, oxycodone extended-release capsules for oral use, submitted by Collegium Pharmaceuticals, proposed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. More information

Patient and Consumer Stakeholder Meeting - MDUFA Reauthorization (Sep 15)

During this meeting, representatives from patient and consumer advocacy groups can hear updates on the FDA-Industry negotiations and provide their suggestions for improving the program. More information

Vaccines and Related Biological Products Advisory Committee Meeting (Sep 15)

The committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis. More information

Science Board to the FDA Meeting (Sep 15)

The Science Board will be provided with a report from the Science Looking Forward subcommittee.More information

Pediatric Advisory Committee Meeting (Sep 16)

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews of several products, as mandated by The Food and Drug Administration Safety and Innovation Act. More information

Public Meeting on Patient-Focused Drug Development for Huntington’s and Parkinson’s Diseases (Sep 22)

FDA is conducting a public meeting on Patient-Focused Drug Development for Huntington’s disease and Parkinson’s disease. FDA is interested in obtaining patients’ perspectives on the impact of patient perspectives on the impact of Huntington’s disease and Parkinson’s disease on daily life and patient views on treatment approaches. More information

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting (Sep 24)

The committee will discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue in growth, which over time results in tubal occlusion. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of the Essure System. The committee will be asked to evaluate currently available scientific data pertaining to the safety and effectiveness of the Essure System, such as events related to implant perforation/migration, device removal, chronic pain, allergic reactions, and unintended pregnancy. More Information

Public Workshop- Surrogate Endpoints for Clinical Trials in Kidney Transplantation (Sep 28)

The purpose of this public workshop is to discuss potential surrogate endpoints for clinical trials of drugs and therapeutic biologics in kidney transplantation, with a focus on endpoints in conditions that represent unmet medical needs. This public workshop is intended to provide information and gain perspective from health care providers, academia, and industry on the role of various laboratories, histologic, and other endpoints used to evaluate patient and allograft outcome in clinical trials of kidney transplantation. More information

2015 PDA/FDA Joint Regulatory Conference (Sep 28 - 30)

"Mission Possible: Patient-Focused Manufacturing, Quality and Regulatory Solutions". Practical solutions and advice for solving some of the current issues facing today’s pharmaceutical industry.More information

Public Workshop - Medical Device Patient Labeling (Sep 29-30)

The FDA is announcing a public workshop entitled “Medical Device Patient Labeling”. The purpose of the public workshop is to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising. The Center for Devices and Radiological Health is seeking input about these topics from patients and advocacy groups, academic and professional organizations, industry, standards organizations, and governmental agencies. More information

Risk Evaluation and Mitigation Strategies: Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access; Public Meeting, Request for Comments (Oct 5-6)

The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, the scientific community, the pharmaceutical industry, public health agencies, patients, patient advocates, health care system administrators, prescribers, dispensers, hospitals, infusion centers, health informatics experts, third-party payers, distributors, and the general public concerning the impact of REMS on the health care delivery system, including the impact on patients and health care providers. The discussion will focus on strategies for characterizing and evaluating the impact of REMS on the health care delivery system and on patient access to drugs subject to REMS.More information

Public Meeting on Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections (Oct 15)

FDA is conducting a public meeting on Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections. FDA is interested in obtaining patients’ perspectives on the impact of Nontuberculous Mycobacterial Lung Infections on daily life and patient views on treatment approaches. More information

Public Workshop - Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use (Oct 16)

FDA is announcing a Public Workshop entitled “Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use.” The purpose of this workshop is to receive input from stakeholders and discuss approaches to establish the performance of non-microbial biomarker assays for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis. More information

Arthritis Advisory Committee Meeting (Oct 23)

The committee will discuss new drug application (NDA) 207988, lesinurad oral tablets, submitted by Ardea Biosciences, Inc., for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor. 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