FDA Resources – August 2014

FDA Resources

What’s New:

August 19th, 2014: “Today, FDA announced the availability of a guidance entitled, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.”  This guidance document is intended to provide clarification regarding the regulatory implications of the decisions that FDA may render based on review of an IDE and to provide a general explanation of the reasons for those decisions. ”

Draft Guidance: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM279107.pdf

FR Notice: http://www.gpo.gov/fdsys/pkg/FR-2014-08-19/pdf/2014-19577.pdf

August 14th, 2014: FDA warns consumers about fraudulent Ebola treatment products- “The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus.”

Read the full statement here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm410086.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

August 13th, 2014: Amgen Issues Voluntary Recall of Aranesp® (darbepoetin alfa) (500 mcg) Prefilled Syringes in Several Countries Outside of the United States Due to the Presence of Visible Particulates-” Amgen (NASDAQ:AMGN) initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp® (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination.”

Read the full press release here: http://www.fda.gov/Safety/Recalls/ucm410011.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Baxter Voluntarily Initiates U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter-“Baxter International Inc. announced today it is voluntarily initiating a recall in the United States of two lots of DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level.”

Read the full press release here: http://www.fda.gov/Safety/Recalls/ucm410010.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

August 12th, 2014: Stem cell therapy: FDA regulatory science aims to facilitate development of safe and effective regenerative medicine products-“One of FDA’s primary missions is to make sure that the products we approve are safe and effective.” 

Read more here: http://blogs.fda.gov/fdavoice/index.php/2014/08/stem-cell-therapy-fda-regulatory-science-aims-to-facilitate-development-of-safe-and-effective-regenerative-medicine-products/?source=govdelivery&utm_medium=email&utm_source=govdelivery

August 11th, 2014: Novartis heart drug study stopped early due to compelling efficacy- “In a 8,442-patient clinical trial, Novartis’ (NYSE:NVS) investigational heart drug LCZ696 met its primary endpoint of reducing hear failure hospitalizations and cardiovascular (CV) deaths compared to the ACE-inhibitor enalapril plus current best treatment for patients with heart failure with reduced ejection fraction. In March 2014 the Data Monitoring Committee overseeing the study confirmed that patients given LCZ696 were significantly less likely to die from CV causes. The results were sufficiently compelling that the study was closed early.”

http://seekingalpha.com/news/1921175-novartis-heart-drug-study-stopped-early-due-to-compelling-efficacy?uprof=45

Glaxo to begin clinical trial of Ebola vaccine-“GlaxoSmithKline (NYSE:GSK) is set to begin a clinical trial of an experimental vaccine against Ebola, which is being co-developed with U.S. scientists.”

http://seekingalpha.com/news/1920715-glaxo-to-begin-clinical-trial-of-ebola-vaccine?uprof=45

McKesson Corp. to Pay $18 Million to Resolve False Claims Allegations Related to Shipping Services Provided Under Centers for Disease Control Vaccine Distribution Contract- “McKesson Corporation has agreed to pay $18 million to resolve allegations that it improperly set temperature monitors used in shipping vaccines under its contract with the Centers for Disease Control and Prevention (CDC), the Justice Department announced today.”

http://www.justice.gov/opa/pr/2014/August/14-civ-841.html

August 8th, 2014: In Vitro Companion Diagnostic Devices- This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product1 (either a novel product or an existing product with a new indication) for which the use of an in vitro companion diagnostic device (or test) is essential for the therapeutic product’s safe and effective use and (2) sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product.

Read more here: Final Guidance

August 4th, 2014: 

Tekmira’s Experimental Ebola Drug Not Used on U.S. Missionary-“The Canadian company that is developing an experimental Ebola drug says its product was not given to one of two American aid workers infected with the virus.”

Read more here: http://www.pharmpro.com/news/2014/08/tekmiras-experimental-ebola-drug-not-used-us-missionary?location=top

Indian drug makers to pay higher facility fees to USFDA. – “Drug makers from India, the biggest source of medicines to the US, may soon have to cough up 12-15% more in annual facility fees as the Food and Drug Administration (FDA) has announced new rates.”

Read more at: http://www.livemint.com/Industry/9PDXawVQqTbpOzTEXY7F9I/Indian-drug-makers-to-pay-higher-facility-fees-to-USFDA.html?utm_source=copy

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