Latest Food and Drug Administration Stories

RAPS will host a virtual workshop featuring regulators and regulatory experts on current communications guidelines and expectations for companies marketing regulated healthcare products in the US. Rockville, MD, USA (PRWEB) April 23, 2013 The Regulatory Affairs Professionals Society (RAPS) will host a virtual workshop, Advertising, Promotion and Labeling: the US Regulated Environment, Monday, 29 April, 12:00–5:00 pm EDT. The program features regulators and regulatory experts on current...

RYE, N.Y., April 23, 2013 /PRNewswire/ -- Curemark LLC announced a successful pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration ("FDA") regarding its CM-AT treatment for Autism. The meeting was held to discuss Curemark's Phase 3 trial results and the pathway for filing an NDA. In view of the positive guidance at this meeting, Curemark will begin filing its NDA. The FDA previously granted Curemark's CM-AT its FAST TRACK designation. "We continue to...

John Castellani, president and CEO, of Pharmaceutical Research and Manufacturers of America will be the keynote speaker. Cole Werble, senior editor of The RPM Report, a highly regarded industry publication, will ensure a day of provocative discussion on relevant issues. NEWARK, N.J., April 23, 2013 /PRNewswire-USNewswire/ -- The Food and Drug Administration is still waiting for pharmaceutical companies to begin submitting the first new medicines in a class of prescription drugs...

Live Webcast from New York on Tuesday, April 30 SAN DIEGO, April 23, 2013 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that Daniel P. Gold, Ph.D., President and Chief Executive Officer, will present at the Needham Healthcare Conference on Tuesday, April 30, 2013 at 2:20 p.m. Eastern time from the Westin Grand Central Hotel in New York City. A live webcast of the presentation can...

BOSTON and TEL-AVIV, Israel, April 23, 2013 /PRNewswire/ -- InspireMD, Inc. (NYSE MKT: NSPR) ("Inspire" or the "Company"), the developer of the MGuard(TM) Embolic Protection Stent (EPS), announced today that on April 19, 2013, the Company received an approval with conditions for its Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA). An approval with conditions indicates that the FDA concurs with the overall trial design and...

Current and Former FDA Advisory Committee Members among Those on 3D Board WASHINGTON, April 23, 2013 /PRNewswire/ -- 3D Communications today announced the formation of a Cardiovascular Advisory Board to further support 3D's work in preparing clients for FDA regulatory submissions and advisory committee meetings. The Cardiovascular Advisory Board is made of of current and former FDA Advisory Committee members and clinicians and surgeons with extensive FDA approval experience. The...

INDIANAPOLIS, April 22, 2013 /PRNewswire/ -- Nora Apothecary & Alternative Therapies today announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to...

David T. Markus Ph.D. Will Host Live Conference Call Series Starting April 24 through April 30, 2013. Irvine, CA (PRWEB) April 22, 2013 EP Global Communications, Inc. (the Company), (Stock Ticker: EPGL) will reveal its new BioMEMS medical device platform, code named "TopSpin", during a series of conference calls hosted by David T. Markus Ph.D. this week. The calls will take place seven consecutive nights this week, starting Wednesday April 24 and concluding Tuesday April 30,...

On Heels Of Today's Supreme Court Ruling On Graphic Cigarette Warnings WASHINGTON, April 22, 2013 /PRNewswire-USNewswire/ -- Today, the U.S. Supreme Court upheld the Food and Drug Administration's (FDA) authority to develop new graphic cigarette warnings that comply with the landmark 2009 law granting the FDA authority over tobacco products, including the requirement for large, graphic cigarette warning labels. The new warnings will help further inform Americans about the deadly...

FIN® BRANDING GROUP GENERAL COUNSEL WILL MAKE APPEAL AT FDA CONFAB WASHINGTON, April 22, 2013 /PRNewswire/ -- The general counsel of FIN Branding Group LLC, one of the fastest growing brands in the electronic cigarette market whose products are sold in more than 35,000 stores nationwide including Walmart, will appeal to the Food and Drug Administration (FDA) next week to consider "reasonable regulation" of the electronic cigarette industry. FIN Branding Vice President and General...