> ## Content Index
> Fetch the complete content index at: https://www.foodconsumer.org/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA News for Health Professionals - 10-22-2014
- URL: https://www.foodconsumer.org/fda_news_for_health_professionals_1022140117/
- Published: 2014-10-22T13:08:00.000Z
- Updated: 2026-09-22T18:42:15.000Z
- Description: An FDA bulletin for health professionals rounding up October 2014 alerts, including recalls of Assured brand naproxen boxes that held ibuprofen, Saba Shark Cartilage Complex over possible salmonella, and Hospira lidocaine injection for particulate matter.
- Author: Food Consumer
- Tags: Government, Health News, #vivvo-import

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.

![HP NL masthead ](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/eed7527adf7f027547ea1c8362c246279168afac.jpg)

**October 22, 2014**

![ocha](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/1e1264e4505937850cb7ac35af6c2552fe8135d9.png)

# PRODUCT SAFETY

| [![mw](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/0b2e6827fe77e5cb74bd9ace2404e3f03f586a4d.png)](http://www.fda.gov/medwatch?ref=foodconsumer.org) **Need Safety Information?** For more important safety information on human drugs, medical devices, dietary supplements and more, please visit [MedWatch](http://www.fda.gov/Safety/MedWatch/default.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery). To receive MedWatch Safety Alerts by email[subscribe here](http://www.fda.gov/Safety/MedWatch/ucm228488.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery). **Problem With a Medical Product?** Tell FDA about problems with human drugs, medical devices and more using the [MedWatch Online Voluntary Reporting Form](https://www.accessdata.fda.gov/scripts/medwatch/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)[ ](https://www.accessdata.fda.gov/scripts/medwatch/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) |
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| ![Medical Product Safety](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/1e129be9bd415248c22266af833b2b011a38d538.jpg) |  | Recall: Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.- Packaging Mix-Up Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured brand Naproxen Sodium tablets because some cartons actually contain bottles of Ibuprofen, a different pain reliever. [More information](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419769.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) |
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### Recall: Saba Shark Cartilage Complex, 60 Capsule Bottles- Possible Salmonella Contamination

AMS Health Sciences, LLC is notifying the public that it is recalling 2014 bottles of Saba Shark Cartilage Complex due to possible contamination of Salmonella, an organism which can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. [More information](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419445.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Drug Safety Labeling Changes- September 2014

Includes 55 products with revisions to Prescribing Information. [More information](http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm417235.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Recall: Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira - Particulate Matter

Hospira announced it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free to the user level due to a confirmed customer report of particulate in a single unit.[ More information](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419322.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Recall: LifeCare Flexible Intravenous Solutions by Hospira, Inc.- Potential for Leakage

Hospira, Inc. announced the voluntary recall of certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage. [More information](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418887.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Field Safety Alert: Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien- Electrodes Will Not Connect with Philips FR3 or FRx AED units

Covidien announced that it has notified customers of a voluntary Field Safety Alert for certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillators.[ More information.](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418644.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Public Notification: Sit and Slim II- Hidden Drug Ingredients

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Sit and Slim II. FDA laboratory analysis confirmed that Sit and Slim II contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. [More information](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418500.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Recall: Oregon Compounding Centers, Inc. Unexpired Sterile Products- Lack of Sterility Assurance

Oregon Compounding Centers, Inc., also called Creative Compounds, is voluntarily recalling certain unexpired human and veterinary sterile products to the consumer level due to lack of sterility assurance. [More information](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418359.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Class 1 Recall: ICU Medical ConMed Stat2 Flow Controller-Delivers Higher Flow Rate than Intended

FDA notified health professionals and their medical care organizations of a Class 1 recall of the Stat2 Flow Controller because it was assembled with the wrong internal component. The Flow Controller may deliver fluid at a much higher flow rate than what is set. [More information](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418345.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Class 1 Recall: CareFusion EnVe and ReVel Ventilators - Power Connection Failure

FDA notified health professionals and their medical care organizations of a Class I Recall of these products. There is a potential for damage to their power cord adaptors which can cause loss of power and complete shut off. [More information](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418344.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Recall: Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.- Uncontrolled Storage During Transit

 Hospira, Inc. issued a voluntary nationwide user-level recall of one lot of Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g Vancomycin (Sterile Powder), NDC 0409-6533-01, Lot 35-315-DD with expiration date of 01 NOV 2015\. [More information](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418065.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Recall: SAM Junctional Tourniquet Accessory (Axilla) Strap - SAM Medical Products- Potential Clip Failure

SAM Medical Products notified customers of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the Axilla application of the SAM Junctional Tourniquet (SJT). [More information](ttp://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418353.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

| ![Blue Shirt/ hand with finger pointing to right](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/2a1449d562901504d73c5a423e1a66f5d0cfd14b.jpg) **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 en[druginfo@fda.hhs.gov](mailto:druginfo@fda.hhs.gov). [Comunicaciones de la FDA](http://www.fda.gov/Drugs/DrugSafety/ucm263010.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) |
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| ![MedWatch Image](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/5051b0767ba5864734aa1de671e17316e0ff302c.jpg) For more important safety information on human drug and devices or to report a problem to FDA, please visit [MedWatch](http://www.fda.gov/Safety/MedWatch/default.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) |
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |

![divider](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/517c6b8897909338c1814dc416a2d32f131f66a3.png)

# PRODUCT APPROVALS & CLEARANCES

| ![Drugs@FDA](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/4c745dfa81bc9ea669768203efc2a64b42f5a24b.gif) For more information on drug approvals or to view prescribing information and patient information, please visit [Drugs at FDA](http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) or[DailyMed](http://dailymed.nlm.nih.gov/dailymed/about.cfm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) |
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| ![FDA Approval](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/86205d39d1c9093da83e31f1b66751d12e2b42f7.jpg) |  | FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic The FDA approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. [More information](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm419288.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) |
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### FDA approves Ofev to treat idiopathic pulmonary fibrosis

The FDA approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF). [More information](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418994.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### FDA approves Esbriet to treat idiopathic pulmonary fibrosis

The FDA approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF). [More information](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418991.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### FDA permits marketing of urinary prosthesis device for women

The FDA allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired detrusor contractility or IDC). [More information](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418835.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### FDA approves a new ultrasound imaging agent

The FDA approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves. [More information](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418509.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### FDA approves first combination pill to treat hepatitis C

The FDA approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection. [More information](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### FDA approves first drug-coated angioplasty balloon catheter to treat vascular disease

The FDA approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease (PAD). [More information](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418455.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### FDA approves Akynzeo for nausea and vomiting associated with cancer chemotherapy

The FDA approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. [More information](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418375.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

![divider](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/517c6b8897909338c1814dc416a2d32f131f66a3.png)

# OPPORTUNITIES FOR COMMENT / GUIDANCES

![Comments - yellow](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/0ce241ac8646ad11cf5f69c39327458aa1e5a1ac.jpg)

### The Effect of Uniform National Policy on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Questions and Answers; Draft Guidance for Industry; Availability

The FDA is announcing the availability of a draft guidance for industry entitled “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers.” FDA is issuing these questions and answers to assist industry and State governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on State product tracing requirements and on standards, requirements, and regulations with respect to wholesale distributor and third-party logistics provider (3PL) licensing. Title II is also referred to as the Drug Supply Chain Security Act (DSCSA).

Although you can comment on any guidance at any time (see [21 CFR 10.115](https://www.federalregister.gov/select-citation/2014/10/08/21-CFR-10.115?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by December 8, 2014 [More information](https://www.federalregister.gov/articles/2014/10/08/2014-23972/the-effect-of-uniform-national-policy-on-drug-product-tracing-and-wholesale-drug-distributor-and?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Prescription Drug User Fee Act Patient-Focused Drug Development; Request for Comments

The FDA is announcing an opportunity for public comment related to FDA's patient-focused drug development initiative. This initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). This effort provides for a more systematic approach under PDUFA V for obtaining the patient perspective on disease severity and currently available treatments for a set of disease areas. FDA is publishing a preliminary list of nominated disease areas for consideration in patient-focused drug development meetings during fiscal years (FYs) 2016-2017\. The public is invited to comment on this preliminary list through a public docket.

Submit either electronic or written comments by December 5, 2014\. [More information](https://www.federalregister.gov/articles/2014/10/08/2014-23965/prescription-drug-user-fee-act-patient-focused-drug-development-request-for-comments?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Patient-Focused Drug Development for Idiopathic Pulmonary Fibrosis; Public Meeting; Request for Comments

The FDA is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for idiopathic pulmonary fibrosis. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of idiopathic pulmonary fibrosis on daily life as well as patient views on treatment approaches for idiopathic pulmonary fibrosis.

The public meeting will be held on September 26, 2014, from 1 p.m. to 5 p.m. Registration to attend the meeting must be received by September 10, 2014 (see SUPPLEMENTARY INFORMATION for instructions). Submit electronic or written comments by November 26, 2014\. [More information](https://www.federalregister.gov/articles/2014/07/08/2014-15871/patient-focused-drug-development-for-idiopathic-pulmonary-fibrosis-public-meeting-request-for?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

![blue border](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/f2ccae96706234624e774bb4a27fbb3f4cc28472.png)

# ANNOUNCEMENTS

### 2014 Ebola Outbreak in West Africa

Information from FDA related to the 2014 Ebola outbreak in West Africa. [More information](http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/ucm410308.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) 

### Consumer Update: Research Flash- FDA Scientists Study Pediatric Brain Function

Study participants repeatedly press a lever on a large machine to make nickels slide out of a tube and drop into a cup. The coins pile up, but this activity in the Food and Drug Administration’s National Center for Toxicological Research (NCTR) laboratory at nearby Arkansas Children’s Hospital (ACH) isn’t a game of luck. It is a game that helps researchers compare important brain functions in children and animals—specifically their memory, attention, motivation, and time perception. The results provide the agency with important insights for the evaluation of the effects of pediatric drugs on psychological processes. [More information](http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm416286.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) 

![divider](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/35ba118f3ddac80c50317ab70ba914c0d34fa686.png)

# UPCOMING MEETINGS

![october](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/eb385b73d306a984c0b89b9e93af1b738db94a8a.png)

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](http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery). Please visit Meetings, Conferences, & Workshops for [more information](http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/default.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) on other agency meetings.

### Collaborative Approaches for Medical Device and Healthcare Cybersecurity - Public Workshop (October 21-22)

The purpose of this workshop is to catalyze collaboration among all stakeholders. Participants identify barriers to promoting medical device cybersecurity; discuss innovative strategies to address challenges that may jeopardize critical infrastructure; and enable proactive development of analytical tools, processes, and best practices by the stakeholder community in order to strengthen medical device cybersecurity. This public workshop will also be Webcast. [More information](http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm412979.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### First Annual Neonatal Scientific Workshop - Roadmap for Applying Regulatory Science to Neonates (October 28-29) 

The purpose of the public scientific workshop is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public to determine whether there is sufficient interest on the part of stakeholders to develop a neonatal consortium and to discuss potential working groups dedicated to the regulatory science required to develop neonatal therapeutics. [More information](https://www.federalregister.gov/articles/2014/09/22/2014-22460/first-annual-neonatal-scientific-workshop-roadmap-for-applying-regulatory-science-to-neonates-notice?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Cardiovascular and Renal Drugs Advisory Committee Meeting (October 30) 

The committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart). [More information](https://www.federalregister.gov/articles/2014/09/17/2014-22071/cardiovascular-and-renal-drugs-advisory-committee-notice-of-meeting?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Development and Regulation of Abuse-Deterrent Formulations of Opioid Medications - Public Meeting (October 30-31) 

The meeting will focus on scientific and technical issues related to the development and in vitro assessment of these products, as well as FDA's approach towards assessing the benefits and risks of all opioid medications, including those with abuse-deterrent properties.The transition to abuse-deterrent formulations of opioid medications presents a number of complex scientific and regulatory challenges. The purpose of this public meeting is to share and solicit comments on the Agency's ongoing work to identify and address these challenges. [More information](https://www.federalregister.gov/articles/2014/09/23/2014-22514/development-and-regulation-of-abuse-deterrent-formulations-of-opioid-medications-public-meeting?source=govdelivery&utm%5Fcampaign=subscription+mailing+list&utm%5Fmedium=email&utm%5Fsource=govdelivery)

![november](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/33bfca975d33a85d1cc2e89ec45caa25cb73f243.png)

### Opthalmic Devices Panel of the Medical Devices Advisory Committee (November 14)

On November 14, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens submitted by applicant Alcon Laboratories, Inc. [More information](http://www.fda.gov/ForPatients/Calendar/ucm416407.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Drug Safety and Risk Management Advisory Committee Meeting Announcement (November 18)

The committee will discuss the Food and Drug Administration Amendments Act of 2007 which requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before the Drug Safety and Risk Management (DSaRM) Advisory Committee. The Agency plans to discuss the risk management of eculizumab (SOLIRIS). The Agency will seek public input whether the REMS with ETASU for this drug assures safe use of the drug, is not unduly burdensome on patient access to the drug, and to the extent practicable, minimizes the burden on the health care delivery system. [More information](http://www.fda.gov/AdvisoryCommittees/Calendar/ucm417986.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### Anesthetic and Analgesic Drug Products Advisory Committee (November 24-25)

The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the product labeling. [More information](http://www.fda.gov/ForPatients/Calendar/ucm417479.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

![december](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/dbb85a4eed0a8b556ad7559cf4448e5a52165886.png)

### 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](https://www.federalregister.gov/articles/2014/09/22/2014-22444/orthopaedic-and-rehabilitation-devices-panel-of-the-medical-devices-advisory-committee-notice-of?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

### 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](https://www.federalregister.gov/articles/2014/09/17/2014-22122/electronic-cigarettes-and-the-public-health-public-workshop?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

![blue divider](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/219d11e19b97d6147a3d2683f249e4e0fa624f0f.png)

# RESOURCES

| ![MWLearn](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/7876883d5839144371fd2b900b3b31721a74ef56.jpg) 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 ](http://www.accessdata.fda.gov/scripts/MedWatchLearn/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) |
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### 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 ](ttp://www.fda.gov/ForHealthProfessionals/ucm274874.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) 

| 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](http://www.fda.gov/AboutFDA/Transparency/Basics/default.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) FDA Voice FDA voice is the official blog from FDA's senior leadership and staff.[More information](https://blogs.fda.gov/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) |  | ![Computer Resource](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/2feead53cb994f8847ddb7e0eb0b461fda3f2cd3.jpg) |
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### 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](http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

![OOCHA](https://storage.ghost.io/c/f5/c2/f5c28c07-f2c7-440d-8161-125a09d9bc91/content/images/2026/08/1fa946ebfe9dc6ce0553fa95305c3edd405d2e21.png)