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Latest Therapeutics Stories

2014-07-26 00:20:52

REDWOOD CITY, Calif., July 25, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for Zalviso(TM) (sufentanil sublingual tablet system). The Company is currently...

2014-07-24 23:11:58

On July 19, healthcare professionals and consumers were notified not to use drugs marketed as sterile produced by Downing Labs LLC, aka NuVision Pharmacy, as they may be contaminated. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 24, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Sterile Drug...

2014-07-24 08:35:12

COLLEGE PARK, Md., July 24, 2014 /PRNewswire-USNewswire/ -- The University of Maryland (UMD) Fischell Department of Bioengineering and UMD's Center of Excellence in Regulatory Science and Innovation (CERSI) will launch a new Graduate Certificate in Regulatory Science and Engineering at the start of the fall 2014 semester. In response to the increasing demand for engineers and technical professionals with graduate-level expertise in both regulatory science and engineering, the new...

2014-07-18 23:01:23

US authorities are holding imports more than ever before, particularly at ports that have a history of holding products, and imports from India. Attend this invaluable webinar and find out how to be in the “Safe Zone” when it comes to dealing with the FDA and Customs. Falls Church, VA (PRWEB) July 18, 2014 Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDA **FDAnews Webinar** Aug. 7, 2014 — 1:30 p.m. – 3:00 p.m. EDT...

2014-07-18 23:01:05

In May 2014, the FDA released a draft guidance that covers the selection and approval process for proposed names of both prescription and nonprescription human drugs and biologics. FDAnews has teamed with drug-naming expert Dr. Susan Proulx to present a 90-minute webinar that will look closely at the draft guidance and its recommended 4-step process. Falls Church, VA (PRWEB) July 18, 2014 Choosing the Right Drug Name: How to Increase Your Chances for Approval **FDAnews Webinar** July...

2014-07-16 16:23:50

WINNETKA, Calif., July 16, 2014 /PRNewswire/ -- Green Cures & Botanical Distribution Inc (OTC Pink: GRCU) ("Green Cures") provided the following updates. CBD Capsules First, Green Cures management announced that due to higher than expected demand for the company's CBD Capsules, Green Cures is presently experiencing a shortage of inventory of these capsules. Customers who had open orders for the CBD Capsules as of July 15, 2014, are currently being notified that the company is...

2014-07-16 08:29:39

CASTLE ROCK, Colo., July 16, 2014 /PRNewswire/-- Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance for and commercializing its CE Marked APPY1(TM) Test, a rapid, multi-analyte assay for aiding in identifying children, adolescent and young adult patients that are at low risk for appendicitis, updated on recent activities concerning its U. S. Food and Drug Administration (FDA) submission for the APPY1 Test that was filed in March 2014. The...

2014-07-09 23:08:49

Innovation Breakdown, a new book by Joseph V. Gulfo, details a broken system and how even the smallest changes can speed up the time to market for medical innovations that save lives. New York, NY (PRWEB) July 09, 2014 Joseph V. Gulfo​, MD MBA​ has successfully brought three medical innovations through the FDA over the course of his 25 year career. But the third time became a decade-long struggle of Herculean proportions, that included an​ unlawful ​withholding of approval by the...

2014-07-04 23:04:02

On June 30, the FDA warned not to use injectable vitamin drug products labeled “Sunshine Labs” and distributed by Medical Supply Liquidators because they are not FDA approved. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 04, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Injectable Vitamin...

2014-06-30 23:14:05

This seminar will provide an in-depth snapshot of the key principles and requirements for advertising and promotion expectations and ensuring compliance success by David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry. San Diego, CA (PRWEB) June 30, 2014 The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the...


Word of the Day
holluschickie
  • A 'bachelor seal'; a young male seal which is prevented from mating by its herd's older males (mated bulls defending their territory).
This comes from the Russian word for 'bachelors.'
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