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Latest Regulatory requirement Stories

2014-09-02 08:29:52

SAN DIEGO, Sept. 2, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the US Food and Drug Administration (FDA) has granted orphan drug status to APD811 for the treatment of pulmonary arterial hypertension. "The FDA Office of Orphan Products Development (OOPD) evaluates scientific and clinical data submissions from sponsors to identify and designate drug candidates that could potentially treat rare diseases to help advance the evaluation and...

2014-08-28 23:15:02

Learn how to navigate an advisory panel from an insider’s perspective. FDAnews has teamed Chris Sloan, Principal Consultant at Quintiles Consulting and former FDA device advisory panelist, and Michael Morton, Medtronic’s chief for global regulatory affairs, in a 90-minute presentation on the FDA advisory panel process. Falls Church, VA (PRWEB) August 28, 2014 FDA Device Advisory Panel Review Process: How to Ensure Successful Outcomes **FDAnews Webinar** Sept. 24, 2014 — 1:30 p.m....

2014-08-05 08:34:32

WARRINGTON, Pa., Aug. 5, 2014 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced financial results for the second quarter ended June 30, 2014, as well as recent business updates. The Company will host a conference call today, August 5, 2014 at 9:00 AM ET to discuss the 2014 second quarter financial results and other business updates. Financial update --...

2014-08-04 08:28:51

HAYWARD, Calif., Aug. 4, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a re-inspection of the Company's Hayward, California manufacturing facility from June 16 to July 31, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations. The FDA did not provide any status or classification to these...

2014-07-29 23:05:06

MarketReportsOnline.com adds "Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)" report to its research store. Dallas, Texas (PRWEB) July 29, 2014 This Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials for imported drug registration but also introduced...

2014-07-29 08:32:31

HAYWARD, Calif., July 29, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a general GMP inspection and a Pre-Approval Inspection (PAI) for RYTARY(TM )at the Company's Taiwan manufacturing facility from July 21 to July 26, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in...

2014-07-25 08:25:54

SAN DIEGO, July 25, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that it will provide a corporate update and report second quarter 2014 financial results before the NASDAQ Global Select Market opens on Friday, August 1, 2014. That same day, Arena will host a conference call and webcast at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for...

2014-07-23 08:31:10

ENGLEWOOD, Colo., July 23 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced the opening of its new headquarters, manufacturing and research facility: Ampio Pharmaceuticals,373 Inverness ParkwayEnglewood, CO 80112Direct: (720) 437-6500 Michael Macaluso, Ampio's CEO, noted "This advanced, labor efficient, pharmaceutical drug manufacturing facility will be fully operational this summer, right on schedule, to produce the first batches of Ampion(TM)...

2014-07-17 08:29:14

NEW YORK, July 17, 2014 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) today announced successful completion and initial results of DPX-110, a Phase 1 skin irritation clinical trial of Locilex® (pexiganan cream 0.8%), the company's novel, broad-spectrum topical antibiotic peptide. Dipexium conducted DPX-110 and the company is conducting DPX-120, a Phase 1 skin sensitization clinical trial, in parallel with two required pivotal Phase 3 clinical trials for Locilex®....

2014-07-02 23:05:52

Cognition is proud to announce Michelle Lott will be joining us as the Executive Advisor for Regulatory Strategy. Bedford, MA (PRWEB) July 02, 2014 Cognition is proud to welcome Michelle Lott as our Executive Advisor for Regulatory Strategy. Michelle’s input will help Cognition better understand regulatory requirements, the ever changing medical device industry standards, and the unique solutions that Cognition’s products like Cockpit provide. Cognition will leverage Michelle’s...


Word of the Day
kenspeckle
  • Having so marked an appearance as easily to be recognized.
This word may come from the Swedish 'kanspak,' quick at recognizing persons or things, or else from confusion with 'conspicuous.'