Tag Archives: FDA

Medical Device Single Audit Program (MDSAP) Mid-Pilot Status

The FDA just released the Mid-Pilot Report for the Medical Device Single Audit Program (MDSAP), to provide the current status of the program’s performance goal and objectives.

The goal of the MDSAP pilot is to provide objective evidence that a regulatory audit of a medical device manufacturer conducted by an MDSAP-recognized auditing organization can fulfill the needs of participating regulatory authorities.  The MDSAP pilot’s objectives include developing the infrastructure, processes, training, and stakeholder commitment necessary to launch the operational phase of the MDSAP in January 2017.

The participating regulatory authorities are the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare, with the Japanese Pharmaceuticals and Medical Devices Agency, and the United States Food and Drug Administration.  The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are official observers.

In a related matter, the new version of ISO 13485 Quality Management System standard, an important element on which the MDSAP Pilot is based, will publish in the coming months.  Two years after the ISO 13485 standard is published, third party auditing organizations or “registrars” may issue industry certifications only to the new version of the standard.

The FDA encourages manufacturers to participate in the MDSAP Pilot prior to the implementation of this key transition initiative, and before the program becomes mandatory in certain regulatory jurisdictions.

For more information about the MDSAP and the participating regulatory authorities, see the FDA’s MDSAP webpage.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health

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Benefits of Early Antiretroviral Therapy in HIV Infection

AIDS is caused by HIV, a retrovirus that attacks the immune system. The virus destroys CD4+ T cells, a type of white blood cell that’s vital to fighting off infection. The number of these cells, known as a CD4+ count, is a key measure of immune system health. After people get infected with HIV, their immune system becomes progressively weaker from the HIV infection, their CD4+ count drops, and eventually they develop AIDS.

AIDS is treated with antiretroviral drugs. These drugs suppress HIV but don’t completely eliminate the virus from the body. Guidelines for when to start treatment differ around the world because the evidence for using antiretroviral drugs when CD4+ counts are higher wasn’t definitive. Some experts felt it prudent to wait until the disease progressed to CD4+ levels at which there was a proven benefit.

The START (Strategic Timing of AntiRetroviral Treatment) study is a randomized, controlled clinical trial designed to more clearly define the optimal time for people with HIV to begin antiretroviral therapy. The study was funded in part by NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and other NIH components.

Researchers in 215 clinics across 35 countries enrolled 4,685 HIV-positive men and women ages 18 and older. All participants had CD4+ counts in the normal range (above 500 cells/mm3) at the time of enrollment and had never taken antiretroviral therapy. They were randomly assigned to 2 groups. The early-treatment group began taking antiretrovirals immediately. The deferral group delayed treatment until their CD4+ counts dropped to 350 cells/mm3 or until they developed AIDS or another condition that required antiretroviral treatment.

The team tracked combinations of outcomes: serious AIDS events (such as AIDS-related cancers or death from AIDS) and serious non-AIDS events (such as cardiovascular disease, end-stage renal disease, liver disease, and non-AIDS-related death).

In May 2015, an independent panel reviewed interim results. They found that the benefits of early antiretroviral therapy far outweighed any risks. The findings were disseminated to study participants, and treatment was offered to everyone in the deferred group.

The research team reported additional findings online on July 20, 2015, in the New England Journal of Medicine. The scientists determined that the overall risk of developing serious AIDS-related events, serious non-AIDS events, or death was reduced by 57% among those in the early-treatment group compared to those in the deferred group. This reduction was seen regardless of age, sex, baseline CD4+ counts, geographic region, or country income level.

Early antiretroviral treatment lowered the risk of serious AIDS-related events by 72%. Early treatment also lessened the risk of serious non-AIDS events by 39%.

A limitation of the study, the researchers note, is that the participants were fairly young, with a median age of 36 years. In addition, they were only followed for 3 years, which is fairly short given that antiretroviral therapy is typically prescribed for a lifetime.

“This study conclusively shows that the benefits of early therapy far outweigh any adverse outcomes, and reinforces recommendations to offer immediate antiretroviral therapy to all HIV patients,” says NIAID Director Dr. Anthony S. Fauci.

Source: FDA.Gov

FDA warns health care professionals not to use compounded or repackaged drugs stored in Becton-Dickinson (BD)

FDA warns health care professionals not to use compounded or repackaged drugs stored in Becton-Dickinson (BD) 3 milliliter (ml) and 5 ml syringes unless there is no suitable alternative available.

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


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.

If you have been using products packaged in these syringes, be aware that using a substitute product may require a dosage adjustment in case the patient has been receiving a subpotent product, or adverse consequences could occur.

BD’s 10ml, 20ml and 30ml syringes may also contain the same rubber stopper. The company is alerting their customers not to use these syringes as a closed container system for compounded and repackaged drugs.

FDA has cleared these syringes as medical devices for general purpose fluid aspiration and injection only.  These syringes were not cleared for use as a closed container storage system for drug products, and the suitability of these syringes for that purpose has not been established.  This issue may extend to other general use syringes made by other manufacturers that were not cleared for the purpose of closed-container storage usage.

FDA has received several reports of compounded and repackaged drugs, such as fentanyl, morphine, methadone and atropine, losing potency when stored in BD 3ml and 5ml general purpose syringes. It is possible that this chemical reaction may affect other compounded and repackaged drugs stored in syringes not FDA cleared for closed-container storage.

Hospital and pharmacy staff should check supply stocks and remove drug products that were filled by pharmacies or outsourcing facilities and stored in general purpose BD 3ml and 5ml syringes.  These syringes are marked with the BD logo at the base of the syringe.

At this time, FDA does not have information on how long drugs can be stored in these syringes before degrading. There is no information to suggest that there is a problem with potency or drug degradation when medication is administered promptly after the syringes are filled.

This warning does not extend to products approved by FDA for marketing as pre-filled syringes, because as part of the approval process, FDA has determined that these products have been shown to maintain stability in the syringe container through the expiration date on the product.

On July 30, 2015, the Institute for Safe Medication Practices (ISMP) issued a Special Alert regarding this problem.  See http://www.ismp.org/newsletters/acutecare/articles/loss-of-drug-potency.aspx

The FDA is continuing to investigate this issue and will provide more information when it is available.

FDA asks health care professionals and patients to report any adverse reactions to the FDA’s MedWatch program:

Source: FDA.gov

New Alzheimer’s, prevention, and caregiving studies enrolling volunteers

 

Interested in participating in Alzheimer’s and related research? Volunteers are needed for the following clinical trials and studies recently added to the National Institute on Aging (NIA) listing. To find out more, click on a trial name below. Contact the study coordinator for your area to learn about participating.

Learn more about volunteering for clinical trials and studies.

Drugs

Cognitive Training/Tests

Caregivers

Registries

  • Alzheimer’s Prevention Registry (nationwide)—get information and updates about participating in future Alzheimer’s prevention trials.
  • Brain Health Registry (nationwide)—sign up for an online study of brain health and learn about possible research-study opportunities.

Major Studies Still Recruiting

Get more information about these and other Alzheimer’s clinical trials. Or, call the ADEAR Center at 1-800-438-4380 (toll-free) or email adear@nia.nih.gov.

Help us spread the word about Alzheimer’s and related clinical trials!

New FDA Drug Safety Communication on Gilenya (fingolimod)

The U.S. Food and Drug Administration is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, information about these recent cases is being added to the drug label.

Patients taking Gilenya should contact their health care professionals right away if they experience symptoms such as new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance. Patients should not stop taking Gilenya without first discussing it with their health care professionals. Health care professionals should stop Gilenya and perform a diagnostic evaluation if PML is suspected.

Gilenya is an immunomodulator shown to benefit patients with relapsing forms of MS. This type of MS causes attacks or relapses, which are periods of time when symptoms get worse. Immunomodulators alter the immune system to reduce inflammation.

To learn more, please visit: Gilenya.

Source: Division of Drug Information (DDI)

Baxter Initiates Voluntary Nationwide Recall

Baxter Initiates Voluntary Nationwide Recall of One Lot of IV Solution Due to the Potential For Leaking Containers, Particulate Matter and Missing Port Protectors

DEERFIELD, Ill., July 30, 2015 – Baxter International Inc. announced today it is voluntarily recalling one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and missing port protectors. Baxter was made aware of these issues through customer complaints.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

 

Carfilzomib FDA Approved

FDA approved carfilzomib (Kyprolis, Onyx Pharmaceuticals, Inc., an Amgen subsidiary) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple ymemloa who have received one to three prior lines of therapy. July 24, 2015.  More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm455873.htm

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

HIV Vaccine Progress in Animal Studies

Research teams achieved important steps needed to prompt the immune system to produce antibodies against HIV. The results show important progress toward design of an effective HIV vaccine.

Source: FDA

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

Cervical spine injury medical treatment guidelines

Source: Colorado Division of Workers’ Compensation

 

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

FDA approved new drug to treat heart failure

On July 7, 2015 the U.S. Food and Drug Administration approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.

Heart failure is a common condition affecting about 5.1 million people in the United States. It is a condition in which the heart can’t pump enough blood to meet the body’s needs. Heart failure generally worsens over time as the heart’s pumping action grows weaker. The leading causes of heart failure are diseases that damage the heart, such as heart attacks and high blood pressure.

Entresto is manufactured by Novartis, based in East Hanover, New Jersey.

For more information go to FDA website @FDA

Source: FDA website

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision