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Latest Regulatory requirement Stories

2014-09-17 08:31:00

HAYWARD, Calif., Sept. 17, 2014 /PRNewswire/ -- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the RYTARY(TM) (IPX066) New Drug Application (NDA) from October 9, 2014, to January 9, 2015. The Company amended the chemical, manufacturing and control (CMC) section of the RYTARY NDA subsequent to...

2014-09-16 12:31:25

SAN FRANCISCO, Sept. 16, 2014 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) reported today that partner AstraZeneca today announced that the US Food and Drug Administration (FDA) approved MOVANTIK((TM)) (naloxegol) tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. Opioids play an important role in chronic pain relief...

2014-09-15 23:03:17

ComplianceOnline, the leading GRC advisory network, and regulatory affairs expert, Dr. Mukesh Kumar will conduct a two day seminar on requirements of SOPs for FDA-regulated industries. Durham, North Carolina (PRWEB) September 15, 2014 ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar on SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations. The two day...

2014-09-11 23:11:35

Three companies—one European, two American—have teamed up to enable European manufacturers of implantable ophthalmic devices to comply with anticipated regulatory demands for ongoing post-market outcomes data. ZURICH, MADISON, WI, and NEW YORK (PRWEB) September 11, 2014 Three companies—one European, two American—have teamed up to enable European manufacturers of implantable ophthalmic devices to comply with anticipated regulatory demands for ongoing post-market outcomes data. In...

2014-09-11 04:20:52

DALLAS, September 11, 2014 /PRNewswire/ -- MarketReportsOnline.com adds Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition) research report of 194 pages to its store. This research not only provides a comprehensive and thorough knowledge of the latest Chinese regulations for imported medical device registration but also introduces the practical operation on how to comply with the Chinese...

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...


Word of the Day
cruet
  • A vial or small glass bottle, especially one for holding vinegar, oil, etc.; a caster for liquids.
This word is Middle English in origin, and ultimately comes from the Old French, diminutive of 'crue,' flask.
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