Blog Posts - Fda

FDA Hepatitis Update - Revised draft guidance on clinical development of treatment for chronic hepatitis C‏

FDA Hepatitis Update - Revised draft guidance on clinical development of treatment for chronic hepatitis C‏The Food and Drug Administration (FDA) has published draft guidance to assist sponsors in the clinical development of direct-acting antiviral...
by HCV New Drug Research on Oct 28, 2013

The Future of Food Additives

According to a new report from Packages Facts, a Rockville, MD-based market research publisher, consumers are driving a change in the reliance on synthetic and artificial ingredients in food products. “Food Additives: The U.S. Market” claims that...
by Zintro Blog on Oct 28, 2013

FDA - Regulations to Curb Prescription Drug Abuse

"F.D.A. Shift on Painkillers Was Years in the Making" by BARRY MEIER and ERIC LIPTON, New York Times 10/27/2013 Excerpt When Heather Dougherty heard the news last week that the Food and Drug Administration had recommended tightening how doctors pr...
by Mage Soapbox on Oct 28, 2013

FDA panel unanimously backs Gilead's hepatitis C drug sofosbuvir

FDA panel unanimously backs Gilead's hepatitis C drug sofosbuvirBy Toni ClarkeWASHINGTON Oct 25 (Reuters) - A federal advisory panel recommended on Friday that the U.S. Food and Drug Administration approve Gilead Sciences Inc's experimental hepatitis...
by HCV New Drug Research on Oct 25, 2013


Rats! I just read an article talking about how Oreo’s can be as addicting as Cocaine. That didn’t really bother me.  I would wager that lots of foods and habit...
by Cognitive ComPost on Oct 16, 2013

FDA Says Rice Tainted With Arsenic Not High Enough To Prove “Immediate Or Short Term Adverse Health Effects”

Renovating Your Mind‘s playbook has FDA acronym standing for Foolish Dumb Agenda. Look out for yourself when it comes to arsenic in rice and other foods. Don’t depend on any government agency to determine the fate of your health. Cigarett...
by Renovating Your Mind on Sep 8, 2013

What To Expect From Gluten-Free Labels

Last week, the Food and Drug Administration defined 20 parts per million as the gluten limit found in products, which have the gluten-free label. The purpose of the new ruling was to protect consumers, suffering from celiac disease and this limit the...
by Zintro Blog on Sep 5, 2013

FDA Guidance Update

According to the Federal Register, the Food and Drug Administration (FDA) has annoucned an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010 to determine their status,...
by Pharmaceutical Microbiology on Aug 29, 2013

FDA appoves Naída CI Q70 sound processor

Advanced Bionics is excited to announce that the new Naída CI Q70 (Naída CI) sound processor has received FDA regulatory approval for commercial release and will soon be available throughout the United States.   WHOO HOO!
by I look so I can hear on Aug 28, 2013

Job Post: Biostatistician/Director of Biostatistics

Job Post: Biostatistician/Director of Biostatistics for a Contract Research Organization (CRO) Location: variable -Client facing -Experience with FDA submissions – NDA, INDs -3 plus years of Biostats experience in a pharma/CRO -experience in Ph...

FDA approval – Now What?

MED-EL recently rolled out the RONDO processor.  Cochlear has just received FDA approval for the Nucleus 6.  And AB is awaiting FDA approval for the Naída CI.  Why isn’t the new hardware available as soon as it has been approved? Read on ̷...
by I look so I can hear on Aug 6, 2013

Nucleus 6 FDA Approval

  Image source: Nyhetsrummet The FDA has given approval to Cochlear’s Nucleus 6! Source: FDA Cochlear Nucleus 6 system...
by I look so I can hear on Aug 5, 2013

GMP Guide for Cosmetic Products (FDA)

The US FDA has published a Good Manufacturing Practice Guide for Cosmetic Products. This is a draft Guideline, and it includes recommendations on documentation, recordkeeping, buildings and facilities, equipment, raw materials, production, internal a...
by Pharmaceutical Microbiology on Jul 17, 2013

FDA issues an inquiry letter to mobile medical app uChek urine analyzer

uChek by Biosense Technologies Pvt is a mobile medical app for the iPhone. Originally designed and used in India, Dr Abhishek Sen from the Biosense team said, "If it can work in India, it can work anywhere" uChek urine analyzer is designed to use t...
by Medical Smartphones on May 30, 2013

FDA Holds Public Workshop on Drug Development for ME/CFS: Day One

On April 25, 2013, the FDA held its first day of public workshops to discuss the impact of CFS/ME symptoms on patients and their caregivers. The purpose of the workshop was to gain insight into developing safe and effective treatments. The first day...
by Onward Through the Fog on May 22, 2013

Seeking Experts To Work On FDA Projects

Institutional Review Board Chairman We require an IRB Chairman expert to provide a written report (and perhaps court testimony) that specifies the obligations of a IRB Chairman when confronted with FDA clinical trial regulatory violations. This is a...
by Zintro Blog on May 17, 2013

FDA Releases Draft Guidance on Labeling Safety

The FDA has issued the following draft guidance: "Guidance for Industry Safety Considerations for Container  Labels and Carton Labeling Design to  Minimize Medication Errors". The introduction to the document states: "The purpose of this...
by Pharmaceutical Microbiology on May 15, 2013

The FDA Patient Network Website - Pretty Darn Patient-Centered

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FDA Releases Guidance on Non-Penicillin Beta-Lactam Drugs

FDA has released a new guidance titled “Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination" (April 2013). In the guidance, FDA stresses the importance of implementing manufacturing controls to prevent cross-conta...
by Pharmaceutical Microbiology on Apr 28, 2013

Robot hot among surgeons but FDA taking a new look

CHICAGO (AP) — A million-dollar robot named da Vinci is hot in operating rooms these days. But problems are giving the high-tech helper new scrutiny. …read more Source: YAHOO   ...
by Tropday on Apr 9, 2013

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