ANNOUNCEMENTS
Treating Infections – FDA is Forging a More Efficient Path to Help Healthcare Providers Treat their Patients
FDA has taken an important first step in implementing a more streamlined process of updating breakpoints for antimicrobial drugs. FDA launched new web pages that contain Susceptibility Test Interpretive Criteria (www.fda.gov/STIC). Our new online system identifying FDA-recognized breakpoints will help laboratories report the most up-to-date information to healthcare providers. This important step is a result of the recently-passed 21st Century Cures Act, which FDA and other agencies are now implementing.
Bringing Early Feasibility Studies for Medical Devices Back to the United States
FDA’s Center for Devices and Radiological Health (CDRH) has an Early Feasibility Studies Program (EFS) that provides a route for innovators, sponsors, FDA review teams, and clinicians to work together to facilitate the early clinical evaluation of medical devices in the United States under the investigational device exemption (IDE) regulations. An EFS is a limited clinical study on a device early in its development, typically before the device design has been finalized, for a specific indication. It may be used to evaluate the device design concept with respect to initial clinical safety and device functionality. The EFS Program includes enhanced opportunities for collaboration, increased regulatory flexibility, and consideration of benefit-risk principles, while maintaining appropriate patient protection measures.
Advancing Policies to Promote Safe, Effective MedTech Innovation
Early in the coming year, FDA’s Center for Devices and Radiological Health (CDRH) intends to advance several important new regulatory policy initiatives to further modernize the medical devices program and continue to foster new medtech innovation. In the first quarter of 2018, FDA intends to publish a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence. This pathway will allow more flexibility to use more modern criteria as the reference standard, and permit comparisons to standards that more closely approximate the kind of novel technology we’re being asked to evaluate.
FDA-Required Studies of Approved Drugs Make a Big Difference for Public Health
Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be both effective and safe for use if prescribed according to its labeling. However, there may be issues that need additional evaluation after approval. For example, post-approval studies may be needed to confirm clinical benefit when a drug is approved under accelerated approval provisions. Additionally, post-approval studies can allow for further evaluation of a potential safety issue or better characterize risk factors for a known safety issue. Once a drug is approved, a larger population and wider range of patients will use the drug than were studied before approval. With this larger experience, new potential safety issues may emerge that were not seen in the studies prior to approval, and such issues may require additional evaluation.
FDA Launches Predictive Toxicology Roadmap to Enable Advances in Toxicity Testing
Toxicology testing plays a pivotal role in ensuring the safety of FDA-regulated products. During the development and evaluation of almost all FDA-regulated products, testing is performed on people or animals to identify any potential risk from chemical, physical, or biological agents. Today, novel methods such as organs on a chip or mathematical modeling are being developed for toxicity testing that are generating unique opportunities to improve our ability to quickly and more accurately predict potential toxicities and reduce associated risks.
CDER Researchers Explore the Promise and Potential of 3D Printed Pharmaceuticals
Most drug products are typically manufactured in large quantities using conventional methods that involve large-scale processes, equipment, and long production time. Emerging advanced manufacturing technology may transform the way some pharmaceuticals are made. One such advanced technology is 3-dimensional (3D) printing. 3D printing can offer a tantalizing step toward changing the manufacturing processes to offer personalized medicines.
Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff
Additive manufacturing, also known as 3-dimensional (3D) printing, is an emerging technology. As a result, this leap-frog guidance is not intended to introduce new policy. Instead it outlines the Agency’s current thinking about the technical aspects associated with additive manufacturing processes, and provides manufacturers with recommendations for device design, manufacturing, and testing considerations for use when developing devices that include at least one additively manufactured component or additively fabricated step.
Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom
This proposed order seeks to reclassify the "single-use female condom" from a class III to a class II device, and rename the device as the “single-use internal condom”. The PO also identifies the special controls that FDA believes are necessary to provide reasonable and continuous assurance of the safety and effectiveness of the reclassified device. FDA is proposing this reclassification based on new information, which was not available at the time of the original premarket approval (PMA) of the device. Submit either electronic or written comments on the proposed order by February 2, 2018.
Pediatric Rare Diseases - A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry
This draft guidance proposes for consideration a novel approach to improve the efficiency of drug development in pediatric rare diseases using Gaucher disease as an example. The emergence of concomitant trials for multiple investigational drug products for the treatment of rare diseases can pose significant challenges to effective drug development, because there are limited numbers of patients for any given rare condition worldwide. This approach discusses the feasibility of the development of multiple drug products in a time-efficient manner while minimizing the number of patients necessary to be treated with placebo. Comment period closes 02/05/2018.
FDA Tobacco Regulatory Science Fellowship
Launched in 2012, this regulatory science fellowship is a collaborative program between the FDA Center for Tobacco Products (CTP) and the National Academy of Medicine. It is designed for mid-career professionals to gain experience and expertise to further define and develop the field of regulatory science as it relates to the regulation of tobacco products and FDA’s authorities under the Family Smoking Prevention and Tobacco Control Act. This is an excellent opportunity for exceptional professionals to actively participate in the development of science-based public health strategies, serve as the lead for defined projects, meet with policy leaders, and acquire new knowledge related to tobacco products and their use, which is the leading cause of preventable death in the United States. The next Call for Applications (CFA) will become available on January 3, 2018.
PRODUCT APPROVALS & CLEARANCES
FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome
The FDA expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy specifically to treat EGPA. According to the National Institutes of Health, EGPA (formerly known as Churg-Strauss syndrome) is a condition characterized by asthma, high levels of eosinophils (a type of white blood cell that helps fight infection), and inflammation of small- to medium-sized blood vessels. The inflamed vessels can affect various organ systems including the lungs, gastrointestinal tract, skin, heart and nervous system.
FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes
FDA approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway).
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.
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.
Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues
The use of impacted alcohol prep pads could result in adverse events such as infections.
Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems
UPDATED 12/05/2017. Anyone currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis.
Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label
Potential for fading print, with more effect on the expiration dating on the patient tear off portion of the vial label.
Bull Capsules, Chao Jimengnan Tablets by Nutra Labs: Recall - Undeclared Drug Ingredients
Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.
DRUG SHORTAGES
- Norethindrone and Ethinyl Estradiol Tablets (Discontinuation)
- Edrophonium Chloride (ENLON) Injection, USP (Discontinuation)
- Edrophonium Chloride, USP and Atropine Sulfate, USP Injection (ENLON-PLUS) (Discontinuation)
- Quinidine Gluconate Injection (Discontinuation)
- Amino Acids (Currently in Shortage)
- Lamotrigine Tablets (Discontinuation)
- Lovastatin Tablets (Discontinuation)
More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood and Biologic Shortages
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.
JANUARY
January 9, 2018: New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products
The focus of this FDA Workshop is on the evaluation of new methods for characterizing and demonstrating equivalence of OINDPs, including discussing the areas in which these methods may significantly contribute to generic product development and regulatory understanding, how and under what conditions the methods should be conducted and evaluated, and inherent scientific challenges with this complex class of products.
January 9, 2018: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
The committee will discuss new drug application (NDA) 206089, oral testosterone undecanoate capsules, submitted by Clarus Therapeutics, for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
January 10, 2018: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
The committee will discuss new drug application (NDA) 208088, oral testosterone undecanoate capsules, submitted by Lipocine Inc. for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
January 11, 2018: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement
The committee will discuss new drug application (NDA) 210693, ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.
January 24, 2018: Tobacco Products Scientific Advisory Committee Meeting Announcement
The committee will discuss modified risk tobacco product applications (MRTPAs), submitted by Philip Morris Products S.A. for IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks.
January 30, 2018: Opioid Policy Steering Committee - Prescribing Information - Exploring a Strategy for Implementation
The purpose of the public hearing is to receive stakeholder input on how FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics.
FEBRUARY
February 2, 2018: FDA/ASCO Hematology and Oncology Fellows Day Workshop
The FDA and the American Society of Clinical Oncology (ASCO) want to leverage their combined strengths for the joint development of this workshop to provide current hematology and oncology fellows with a solid foundation in the process of oncology drug development and regulatory science. This workshop will be open to physicians who have completed at least one year of hematology/ oncology fellowship training in an accredited U.S. training program and are currently in good standing in their fellowship program. Fellows in their final year of training will be given preference.
February 7-8, 2018: 10th Annual Sentinel Initiative Public Workshop
The purpose of this two day public workshop is to bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Day 1 will be convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with the FDA. Key discussion topics will include an update on the state of FDA’s Sentinel Initiative, key safety surveillance activities, and emerging uses of the Sentinel System. Day 2 will address more advanced topics, including Sentinel’s inferential analytic capabilities, and methods of identifying unexpected safety concerns. Attendees will leave with a deeper understanding of how to use the Sentinel System tools to address safety questions.
RESOURCES
For more important safety information on human drug and devices or to report a problem to FDA, please visitMedWatch, The FDA Safety Information and Adverse Event Reporting Program
Opportunities for Comment
The FederalRegister.gov website was developed to make it easier for citizens and communities to understand the regulatory process and to participate in Government decision-making. The Office of the Federal Register of the National Archives and Records Administration and the U.S. Government Publishing Office jointly administer the FederalRegister.gov website. Search for opportunities to comment on FDA Public Notices.
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
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
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
FDA Voice
FDA voice is the official blog from FDA's senior leadership and staff. More information
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