January 24, 2018
New policy steps for strengthening public warning and notification of recalls
FDA published a draft guidance that better describes the FDA’s policy on public warning and notification of recalled products as part of our effort to ensure better, more timely information reaches consumers. Although we often hear the most about recalled food, this guidance also covers other FDA-regulated products including drugs, medical devices and cosmetics.
FDA’s ongoing commitment to employing a least burdensome approach to device review
To encourage innovation and provide patients with access to the latest safe and effective medical technologies, we continually strive to make the device development and regulatory review process more modern, science-based and efficient. A key feature of these efforts is early and more thorough engagement with innovators to help them meet the FDA’s science-based requirements in a way that allows companies to bring safe, effective modern devices to patients as soon as possible. This approach is one aspect of what we refer to as “least burdensome.”
Update on FDA’s ongoing efforts to increase access to complex generic drugs
GAO report on complex generic drugs recommends that FDA make public its plans to issue or revise guidance; FDA agrees and is actively working to accomplish this goal.
Updates on some ongoing shortages related to IV fluids
Based on the information we’re receiving from companies and the actions we’ve taken at FDA, we continue to expect that the shortage of IV fluids will improve in the coming weeks and months. In addition to working with manufacturers to ensure that their Puerto Rico facilities can operate at full capacity, we’ve worked with manufacturers such as Baxter and B. Braun to import product into the U.S. from their foreign facilities including most recently from a Baxter facility in Brazil.
FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel
The framework for the program was put in place through H.R.4374, which authorized DoD to request, and the FDA to provide, assistance to expedite development and the FDA’s review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel. Utilizing this law’s expanded authorities, the FDA will work closely with Health Affairs to better understand the military’s medical needs for deployed personnel; give the highest level of attention to and expedite its review of priority DoD medical products in a manner similar to products under the breakthrough designation program; provide ongoing technical advice to Health Affairs to aid in the rapid development and manufacturing of medical products for use by the military; and, take a closer look at products currently under development to determine opportunities to expedite their availability.
New steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
Scientific progress and new drug innovation don’t take place in a vacuum. The exchange of information that informs decisions to undertake research, invest in new scientific endeavors, and prescribe and use certain treatments effectively are a critical part of enabling the development and dissemination of new medical technology. Transparency related to this information can play a critical role in maximizing the public health value of the resulting innovations.
FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the 'intended use’ of medical products
The FDA is committed to ensuring that we have the right policies and processes in place to fulfill our public health mission. This includes providing clear rules to medical product manufacturers about fundamental issues such as how the FDA will determine the intended use of a medical product. We heard concerns that the FDA’s final rule to amend the agency’s existing intended use regulations – put forward a year ago in January 2017 – wasn’t clear, and we’re committed to addressing this important issue.
FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use
FDA announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning.
Shortages/discontinuations voluntarily reported by manufacturers during the past 2 weeks:
- Sterile Water (Currently in Shortage)
- Methylphenidate Hydrochloride (QUILLICHEW ER) Extended-Release Chewable Tablets (Currently in Shortage)
- Methylphenidate Hydrochloride (QUILLIVANT XR) for Extended-Release Oral Suspension (Currently in Shortage)
- Dronabinol Capsules (Discontinuation)
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate (LOESTRIN Fe) Tablets (Discontinuation)
- Dextrose 5% Injection Bags (Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
- Cefepime Injection (Currently in Shortage)
- Norethindrone and Ethinyl Estradiol Tablets (Discontinuation)
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
PRODUCT APPROVALS & CLEARANCES
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
FDA expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation. Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx.
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed
Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
"Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter
UPDATED 01/23/2018. Recall expanded to include a second lot (NC109123). Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.
Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved Misbranded or unapproved new drugs present serious public health risks.
Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling
Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses.
Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter Use of a non-sterile injectable product could result in fatal infections.
Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure
Failure to immediately replace the device after Message Code 102 appears may result in serious patient harm or death of the patient because the device may fail to deliver therapy when needed.
Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions
Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock.
Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events
CORRECTION to January 11, 2018 letter. Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement.
Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced
General use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products.
LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results
UPDATED 01/11/2018. FDA warns Becton Dickinson & Company of significant violations of law as part of ongoing investigation into lead testing issues.
Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes
Risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.
Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow
Embolism could obstruct blood flow to critical organs, leading to serious injury and/or need to surgically extract overflow material from the patient. Severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result.
Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling
Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening.
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 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.
FDA Approach to Evaluating Nicotine Replacement Therapies (Jan 26)
A majority (roughly 70%) of adult smokers in the United States report that they want to quit, and nearly half of them make a quit attempt each year. Many of those quit attempts involve the use of NRT products, which are designed to help people quit smoking by supplying controlled amounts of nicotine to ease their withdrawal symptoms. The Agency is committed to increasing access to and use of nicotine replacement therapy that which could help more smokers quit. FDA believes it is critical to obtain input from researchers, health care professionals, manufacturers, interested industry and professional organizations, the public health community, and the public regarding how evolving science could influence FDA’s approach to evaluating the safety and effectiveness of NRT products.
Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology (Jan 29)
The goal of precision oncology is to use a cancer patient's genetic data to help determine which therapeutic(s) might be most effective in treating their disease. Next generation sequencing (NGS) is increasingly employed in oncology because the technology can be used to screen for a large number of mutations simultaneously to optimize and personalize patient care. The increasing number of reported mutations may lead to uncertainty for clinicians in the interpretation and prioritization of the variants with respect to the clinical significance and optimal course of action, respectively. FDA is holding this public workshop to engage stakeholders and solicit input from experts in precision oncology to discuss how genetic sequencing data is best implemented in patient management so that innovative regulatory strategies can be advanced to support the development of safe and effective precision-based drugs and devices for marketing.
Opioid Policy Steering Committee - Prescribing Information - Exploring a Strategy for Implementation (Jan 30)
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.
Model Informed Drug Development (MIDD) for Oncology Products (Feb 1)
Over the past few decades, there has been extensive investment in oncology drug discovery and development. Despite greater understanding of disease biology and drug mechanisms of action, further progress in model-informed strategies is needed to continue advancements in oncology drug development. Innovations in clinical trial design utilizing more informative endpoints could help bring more effective treatment options to cancer patients faster by accelerating development of effective new drugs and reducing failure rates in expensive late-phase development.
FDA-AACR-ASTRO Regulatory Science and Policy Workshop - Clinical Development of Drug-radiotherapy Combinations (Feb 22-23)
There is great interest among clinicians as well as regulatory authorities to address the lack of drug development for products intended specifically for use with radiation therapy. Emerging from the enthusiasm and momentum of a session at the AACR-sponsored Accelerating Anticancer Agent Development and Validation Workshop (May 3-5, 2017, Bethesda, Maryland), this two-day workshop will bring together regulatory agencies, industry, and academia to discuss the challenges in greater depth and come up with a path forward.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting (Feb 14)
The committees will be asked to discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees will also be asked to discuss the abuse potential of this non-abuse-deterrent product and whether it should be approved.
Anesthetic and Analgesic Drug Products Advisory Committee Meeting (Feb 14-15)
The committee will discuss supplemental new drug application (sNDA) 022496/S-009, for EXPAREL (bupivacaine liposomal injectable suspension), submitted by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia.
Neurological Devices Panel of the Medical Devices Advisory Committee Meeting (Mar 1)
the committee will discuss, make recommendations, and advise FDA regarding the evaluation of clinical study data to support the safety and effectiveness of intracranial aneurysm treatment devices and factors that can affect clinical outcomes such as aneurysm morphology, size, and location in the neurovasculature. FDA is also convening this committee to seek expert opinion on the scientific and clinical considerations relating to the clinical trial design that may be relevant to the determination of safety and effectiveness for these devices.
IASLC-FDA Lung Cancer Neoadjuvant Meeting (Mar 1-2)
This initial meeting between the FDA, the IASLC, industry and investigators is designed to facilitate discussions regarding the standardization of endpoints in neoadjuvant lung cancer trials and to discuss how said endpoints can be validated by comparing novel endpoints to established time to event endpoints.
Gastrointestinal Drugs Advisory Committee Meeting (Mar 8)
The committee will discuss supplemental new drug application (sNDA) 203214, supplement 18, XELJANZ (tofacitinib) 5 mg and 10 mg tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response or intolerance to corticosteroids, azathioprine, 6-mercaptopurine or tumor necrosis factor (TNF) inhibitor therapy.
Oncology Center of Excellence Listening Session; Public Meeting (Mar 15)
The purpose of the public meeting and the docket for comments is for stakeholders to provide recommendations to the Agency regarding FDA's OCE. Specifically, the Agency solicits comments regarding what stakeholders desire of the OCE in terms of structure, function, regulatory purview, and activity.
Pediatric Advisory Committee Meeting (Mar 23)
Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. The Pediatric Advisory Committee will meet to discuss the following products:
Center for Drug Evaluation and Research: BANZEL, INTUNIV, LEXAPRO
Center for Devices and Radiological Health: FLOURISH (HDE), ACTIVA (HDE), LIPOSORBER (HDE), IMPELLA RP SYSTEM (HDE)
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
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Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
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FDA Expert Commentary and Interview Series on Medscape
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Cardiovascular and Endocrine Liaison Program
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Medical Product Safety Network (Medsun)
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