Latest Food and Drug Administration Stories

Addition of senior executive reflects the company's growth SAN FRANCISCO, May 2, 2013 /PRNewswire/ -- Today, Validant, a leading Quality and Regulatory services firm to global biotechnology, pharmaceutical, and medical device companies, named Michael Beatrice, PhD, as company President. In this role, Mike will assume oversight of all existing client operations and lead the design and development of future service offerings. "Mike will draw from his broad experience and strong...

Cats with renal disease also may have "silent killer" RALEIGH, N.C., May 2, 2013 /PRNewswire/ -- The largest known veterinary clinical trial of its kind with 35 study sites in the United States and Canada is currently evaluating cats with kidney disease to determine if they also have hypertension (high blood pressure). Kidney disease and hypertension often occur together, especially in older cats. Hypertension has been called a "silent killer" and is difficult to diagnose because...

GERMANTOWN, Md., May 2, 2013 /PRNewswire/ -- RNL BIO, a stem cell biotechnology company dedicated to the commercialization of autologous cell therapy products for a variety of degenerative, ischemic and other indications, has announced that it has filed an Investigational New Drug application (IND) with the Food and Drug Administration (FDA) to begin clinical trials with its adipose-derived stem cell product, termed RNL-JointStem, for the treatment of osteoarthritis (OA). Assuming...

2013 Q1 NME FDA approvals indicates drug names are trending to longer lengths, more syllables and greater distinction. NEW YORK, May 2, 2013 /PRNewswire-iReach/ -- For the first quarter of the 2013 calendar year, the FDA's Center for Drug Evaluation and Research (CDER) has approved nine new molecular entities. A total of 39 novel new medicines were approved in 2012, the highest total in sixteen years. Our conclusions are based on a comparison of the average number of letters and...

redOrbit Staff & Wire Reports - Your Universe Online The Food and Drug Administration (FDA) approved on Tuesday the over-the-counter sale of morning-after pills for those 15 years of age and older, and will make the pills available on store shelves, rather than being sold from a pharmacy. Until now, emergency contraception has been available by prescription only to those under the age of 17, and was only sold from behind pharmacy counters. The FDA ruling, which takes effect...

WASHINGTON, May 2, 2013 /PRNewswire/ -- "A May 2013 report titled, Concentrations and Potential Health Risks of Metals in Lip Products from the University of California at Berkeley analyzed 32 lip products (lipsticks and lip glosses) to measure levels of nine metals - lead, aluminum, cadmium, cobalt, chromium, copper, manganese, nickel, and titanium. The report does not provide any new meaningful information. The finding of trace levels of metals in lip products is not unexpected...

U.S. commercial launch anticipated by end of Q2 2013 NOVATO, Calif., May 1, 2013 /PRNewswire/ -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq: RPTP), today announced that the U.S. Food and Drug Administration (FDA) has approved PROCYSBI(TM) (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older. In a Phase 3 study, PROCYSBI showed consistent cystine depletion over the full 12-hour...

Enhanced Functionality Adds Even Greater Efficiency SAN FRANCISCO, May 1, 2013 /PRNewswire/ -- goBalto, Inc. released new file management and site collaboration capabilities in the latest version of Tracker 2.0, the company's cloud-based solution that helps accelerate clinical trial startup. Tracker 2.0, goBalto's flagship product, is a software-as-a-service (SaaS) application that helps pharmaceutical, biotech, medical device companies, and small or large clinical research...

PDUFA goal date set for October 17, 2013 ATLANTA, May 1, 2013 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that its recent resubmission of the New Drug Application (NDA) for ILUVIEN(®) has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a complete class 2 response to the FDA's...

SAN ANTONIO, May 1, 2013 /PRNewswire/ -- BiO2 Medical, Inc., a Texas based medical device manufacturer with corporate offices in San Antonio, Texas, and R&D and manufacturing operations in Golden, Colorado, is among the first to receive U.S. Food and Drug Administration (FDA) approval of their Investigational Device Exemption (IDE) application to begin an Early Feasibility Pilot Study (EFPS) using the Angel(TM) Catheter. The Angel(TM) Catheter is the first to combine the...