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This annual conference brings together leading authorities from FDA, industry, and academia to address statistical issues related to medical technology clinical studies
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A government shutdown will severely restrict food and drug inspections. The FDA will not be able to conduct specific inspections of drug or medical device manufacturing facilities.
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A pair of hearings on Capitol Hill this week aim to peer closely at how the medical device industry interacts with regulators at the FDA.
View ArticleProtected: OneMedRadio: The JOBS Act — Promises and Pitfalls
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VisionCare's lead product, Implantable Miniature Telescope by Dr. Isaac Liphitz, enlarges images in front of the eye approximately 2.5 times their normal size.
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IntelGenx is at the forefront of the industry with CPI-300 being the only single dose 450 mg formulation of Bupropion HCl approved by the FDA.
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The Food and Drug Administration must act quickly to enforce a largely ignored 35-year-old mandate prohibiting non-medical use of antibiotics in farm animals.
View ArticleYour Biotech Calendar, August 28: PDUFA Dates, SEC Filings, Financings
At OneMedPlace, our goal is to be your eyes and ears to the biotech and life sciences sector: putting into perspective what we've seen so far, and providing you with snapshots of and what's upcoming.
View ArticleObesity Drug Market: Can Dramatic Returns Outweigh the Risk?
Arena and Vivus' approval of their obesity drugs -- the first such approved in 13 years -- have sent shockwaves throughout the industry. With Orexigen's drug on the way, these have the potential to...
View ArticlePDUFA: Sept 30 — NPS Pharmaceuticals
NPS Pharmaceuticals expects an FDA decision under the Prescription Drug User Fee Act (PDUFA) on the approval status of GATTEX, being developed for the treatment of adult short bowel syndrome.
View ArticleOneMedRadio: Intellicell BioSciences CEO Talks Stromal Vascular Cells
Intellicell BioSciences (OTC: SVFC) has pioneered a unique method of acquiring stromal vascular fraction cells derived from the blood vessels in the adult adipose tissue. The company's proprietary...
View ArticleOneMedRadio: DARA BioSciences CEO on Oncology Market Opportunity, Key Catalysts
In Part II of our discussion with DARA Biosciences (NASDAQ: DARA) CEO and Chief Medical Officer Dr. David Drutz, we look into key catalysts for the specialty pharmaceutical company. Dr. Drutz discusses...
View ArticleMeaningful Use, The Affordable Care Act, Sequestration, and Medical Devices
The Healthcare ecosystem in the United States is changing dramatically due to significant regulations and legislation. Though Obamacare gets the most attention for its impact on patient care and...
View ArticleAcadia Forges Forward With Pimavanserin
On March 12, 2013, Acadia Pharmaceuticals (ACAD) reported financial results for the fourth quarter and full year 2012. Total revenues in the quarter were $0.4 million, essentially in-line with our...
View ArticleMAPPING THE B.R.A.I.N.
On April 2nd, 2013, U.S. President Barack Obama unveiled the “BRAIN” Initiative, which is short for Brain Research through Advancing Innovative Neurotechnologies. The BRAIN Initiative may be known as...
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