Latest Food and Drug Administration Stories

- IIMD China 2013 Hot Topics Preview SHANGHAI, May 17, 2013 /PRNewswire/ -- Medical devices are any medical items that are neither a drug nor a biological product. In light of their different mechanisms, actions and regulatory requirements, medical device (MD) trail evaluations are much more complicated than drug trails due to their unique clinical practices. Currently, the EMEA only evaluates MD safety instead of evaluating both safety and efficacy (which is left to the...

SAN DIEGO and CAMBRIDGE, Mass., May 17, 2013 /PRNewswire/ -- Shareholder rights attorneys at Robbins Arroyo LLP announce that a purchaser of Aveo Pharmaceutical, Inc. (NASDAQGS: AVEO) securities has filed a complaint in the U.S. District Court for the District of Massachusetts. The complaint alleges that Aveo and certain of its officers violated the Securities Exchange Act of 1934 (the "Exchange Act") between January 3, 2012 and May 1, 2013 (the "Class Period"). (Logo:...

WASHINGTON, May 17, 2013 /PRNewswire-USNewswire/ -- Personalized medicine and targeted therapies hold great potential to improve patient care and health care efficiency. At the Ninth Annual State of Personalized Medicine Luncheon hosted by the Personalized Medicine Coalition (PC), Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research at the Food and Drug Administration (FDA), will discuss how the FDA is dealing with the expanding field of personalized medicine,...

Committee to Review Respiratory Safety Data Comparing MOXDUO with Components SYDNEY and BEDMINSTER, N.J., May 17, 2013 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the US Food and Drug Administration (FDA) has set 17 July 2013 as the date of the Advisory Committee meeting to consider the Company's resubmitted MOXDUO( )New Drug Application (NDA). "The timing is within the expected date range of late June to late July," said Dr. John Holaday,...

JERUSALEM, May 17, 2013 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule. "We are very pleased to have the FDA clearance to proceed," stated Nadav Kidron, CEO of Oramed. "The upcoming trial is a major milestone...

CANTON, Mass., May 17, 2013 /PRNewswire/ -- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that the Company's President and CEO, Michael Heffernan, will present the Company's corporate overview on Monday, May 20, 2013 at 1:30pm EDT at the UBS Global Health Care Conference. The conference will be held at the Sheraton New York Hotel in New York City. The Company's lead development program is Oxycodone DETERx(®), an abuse-deterrent,...

PITTSBURGH, May 17, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has shipped Fenofibrate Tablets, 48 mg and 145 mg. Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is the generic version of Abbvie Inc.'s Tricor(®) Tablets. Fenofibrate Tablets are indicated as adjunctive therapy to diet to reduce...

As more and more patients are reporting serious injury after being treated with transvaginal mesh and bladder slings, the dangerous products lawyers at the Law Offices of James Scott Farrin are meeting with patients who received the devices to discuss their legal rights and a possible claim for compensation. Durham, NC (PRWEB) May 16, 2013 As more and more patients are reporting serious injury after being treated with transvaginal mesh and bladder slings, the dangerous products lawyers at...

The Study Data Reviewer’s Guide Template, a creation of the FDA/PhUSE Working Group collaboration is now available. The Study Data Reviewer’s Guide documents, in a human-readable way, data life-cycle decisions to aid the FDA review of licensing applications. Silver Spring, MD (PRWEB) May 16, 2013 PhUSE announces the availability of the Study Data Reviewer’s Guide (SDRG) Template. The FDA is currently reviewing the implementation/utility of this document and encourages sponsors to...

http://www.DrugRisks.com is the most helpful resource on the web for prescription medication alerts, side effects and legal news. Visit us today New York, NY (PRWEB) May 16, 2013 The prescription device safety center at DrugRisks.com is announcing updated information on the site for women using the IUD contraceptive Mirena. News from a federal judicial panel show the number of patients filing claims alleging injury from the devices is growing*. The goal of DrugRisks is to improve the...