NEWSLETTER UPDATE
The Health Professional Newsletter brought to you by the Office of Health and Constituent Affairs is looking to improve and streamline our communications to you in the near future. Thank you for your subscription and we also want to make you aware that FDA has over 130 email self-subscription notification at no cost and you can even tailor the way and frequency you receive updates from FDA.
You can view the complete list of FDA subscriptions by visiting: http://go.fda.gov/
ANNOUNCEMENTS
FDA In Brief: FDA brings additional efficiency and modernization to regulation of digital health, as part of the Digital Health Innovation Action Plan
The FDA recognizes that it can help encourage digital health innovation by making its policies and processes more efficient and modernizing its regulatory tools. As part of the FDA’s Digital Health Innovation Action Plan issued in 2017, the agency committed to developing a new regulatory framework for reviewing software as a medical device and issuing a suite of guidances to provide transparency and clarity to product developers about the agency’s regulatory process.
FDA, FTC Take Action Against Companies Misleading Kids With E-liquids that Resemble Children’s Juice Boxes, Candies and Cookies
As part of ongoing efforts to protect youth from the dangers of nicotine and tobacco products, today the U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued 13 warning letters to manufacturers, distributors, and retailers for selling e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products, such as juice boxes, candy or cookies, some of them with cartoon-like imagery. Several of the companies receiving warning letters were also cited for illegally selling the products to minors.
Mission Possible: Moving the Needle Forward to Advance Health Equity, by: CAPT Richardae Araojo
Every April our country observes National Minority Health Month to spotlight what we’re doing to eliminate health disparities among minority populations. A health disparity is a particular type of health difference that is closely linked with social and economic disadvantage, discrimination, or exclusion. We strive for what we call health equity―the attainment of the highest level of health for all people―by enlisting a range of approaches to remove the social and economic obstacles to health faced by racial and ethnic groups.
DRUG SHORTAGES
FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients. The following list includes drugs currently in shortage, shortages recently resolved and drugs that have been discontinued.
- Isoniazid Oral Tablets (Discontinued)
- Lidocaine HCl Topical Jelly (Discontinued)
- Stavudine Capsules (Discontinued)
- Magnesium Sulfate Injection (New)
- Methadone Hydrochloride Injection (New)
PRODUCT APPROVALS & CLEARANCES
- CBER: What's New for Biologics
- CDER: Recently Approved New and Generic Drugs
- CDRH: 2018 Device Approvals
PRODUCT SAFETY
Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction
FDA is requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.
Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry
FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment.
For important safety information on human drugs, medical devices, dietary supplements and more, or to report an adverse event or problem with a medical product, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program.
FDA is requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.
Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry
FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment.
For important safety information on human drugs, medical devices, dietary supplements and more, or to report an adverse event or problem with a medical product, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program.
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 the following FDA pages to see up-to-date information on upcoming public meetings.
- FDA - Advisory Committee Section
- FDA - Workshops, Meetings, and Conferences (non-advisory committee)
- CBER (Biologics) - Workshops, Meetings and Conferences
- CDER (Drugs) - Workshops, Meetings and Conferences
- CDRH (Medical Devices) - Workshops, Meetings and Conferences
- CFSAN (Food Safety) - Workshops, Meetings and Conferences
CONTINUING EDUCATION
CDERLearn Training and Education
CDERLearn in the Center for Drug Evaluation and Research (CDER) offers a variety of learning opportunities for healthcare professionals, industry, consumers, and academia. The goal is to create a body of educational and information modules about human drug regulation and activities. CDERLearn is a way to share FDA expertise in specific subject areas to further instruct the public about the many ways CDER protects and promotes public health.
.png)
No hay comentarios:
Publicar un comentario