Regulatory Blog and News http://www.pharmstatus.com/regulatory/blog.html Links, guidelines, updates about regulatory writing for FDA, EU, and ICH documents. en-US Copyright 2009 Sat, 28 Feb 2009 16:01:15 -0800 Sat, 28 Feb 2009 16:01:15 -0800 http://thingamablog.sf.net http://blogs.law.harvard.edu/tech/rss Phase I Dosing for Cancer Drugs Detailed in New ICH Guidance <p><a href="http://www.fdanews.com/newsletter/article?articleId=114968&amp;issueId=12438" target="blank">FDA News Source</a><br /> <a href="FDA-2009-D-0006-gdl.pdf">FDA draft guidance</a></p> <p> Phase I clinical trials of cancer drugs can include maximum...</p> http://www.pharmstatus.com/regulatory/archives/02-01-2009_02-28-2009.html#39 http://www.pharmstatus.com/regulatory/archives/02-01-2009_02-28-2009.html#39 guidelines Sat, 28 Feb 2009 16:01:14 -0800 FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events <p><a href="http://www.fda.gov/bbs/topics/NEWS/2009/NEW01956.html" target="blank">FDA News Source</a><br /> <a href="http://www.saeconsortium.org" target="_blank">International Serious Adverse Event Consortium</a><br /> <a href="http://www.fda.gov/oc/initiatives/criticalpath" target="_blank">FDA’s Critical Path Initiative</a></p> <p> The first...</p> http://www.pharmstatus.com/regulatory/archives/02-01-2009_02-28-2009.html#38 http://www.pharmstatus.com/regulatory/archives/02-01-2009_02-28-2009.html#38 guidelines Sat, 28 Feb 2009 15:55:24 -0800 FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India <p><a href="http://www.fda.gov/bbs/topics/NEWS/2009/NEW01962.html" target="blank">FDA Source</a></p> <p> Agency halts review of drug applications from plant due to evidence of falsified data;...</p> http://www.pharmstatus.com/regulatory/archives/02-01-2009_02-28-2009.html#37 http://www.pharmstatus.com/regulatory/archives/02-01-2009_02-28-2009.html#37 news Sat, 28 Feb 2009 15:50:49 -0800 FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs <p><a href="http://www.fda.gov/bbs/topics/NEWS/2009/NEW01963.html" target="blank">FDA Source</a></p> <p>Agency warns against chronic use of these products to treat gastrointestinal disorders</p> <p>...</p> http://www.pharmstatus.com/regulatory/archives/02-01-2009_02-28-2009.html#36 http://www.pharmstatus.com/regulatory/archives/02-01-2009_02-28-2009.html#36 news Sat, 28 Feb 2009 15:48:20 -0800 Elite Announces Drug Application Filing For Synthetic Narcotic Analgesic Accepted by FDA <p><a href="http://www.globenewswire.com//newsroom/news.html?ref=rss&amp;d=151126" target="blank">Globes News Wire Source</a></p> <p> Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (AMEX:ELI) in collaboration with ThePharmaNetwork,...</p> http://www.pharmstatus.com/regulatory/archives/10-01-2008_10-31-2008.html#35 http://www.pharmstatus.com/regulatory/archives/10-01-2008_10-31-2008.html#35 news Thu, 02 Oct 2008 14:10:15 -0700 FDA Offers Advice on End of Phase IIa Meetings <p><a href="http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0514-gdl.pdf" target="blank">FDA Source</a></p> <p> The FDA is recommending that IND sponsors meet with the agency at the end...</p> http://www.pharmstatus.com/regulatory/archives/10-01-2008_10-31-2008.html#33 http://www.pharmstatus.com/regulatory/archives/10-01-2008_10-31-2008.html#33 guidelines Thu, 02 Oct 2008 14:05:10 -0700 U.S. Food & Drug Administration Approved the use of REYATAZ® (atazanavir sulfate) Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients <p><a href="http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&amp;newsId=20081001006635&amp;newsLang=en" target="blank">Business Wire Source</a></p> <p> Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food &amp; Drug...</p> http://www.pharmstatus.com/regulatory/archives/10-01-2008_10-31-2008.html#32 http://www.pharmstatus.com/regulatory/archives/10-01-2008_10-31-2008.html#32 news Thu, 02 Oct 2008 14:01:04 -0700 Process Validation Guidance to Focus on Testing Upfront <p><a target="blank" href="http://www.fdanews.com/newsletter/article?articleId=110237&amp;issueId=11941">FDA News Source</a></p> <p> The FDA will emphasize more oversight and batch testing in the early stages...</p> http://www.pharmstatus.com/regulatory/archives/09-01-2008_09-30-2008.html#31 http://www.pharmstatus.com/regulatory/archives/09-01-2008_09-30-2008.html#31 guidelines Wed, 10 Sep 2008 17:22:20 -0700 Prescription Drug Advertising Subject of New FDA Web Site for Consumers <p><a target="blank" href="http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&amp;STORY=/www/story/09-05-2008/0004879743&amp;EDATE=">PR News Wire Source</a></p> <p> EthicAd, a nonprofit organization devoted to improving public health through consumer education,...</p> http://www.pharmstatus.com/regulatory/archives/09-01-2008_09-30-2008.html#26 http://www.pharmstatus.com/regulatory/archives/09-01-2008_09-30-2008.html#26 news Fri, 05 Sep 2008 21:26:41 -0700 FDA to List Drugs Under Review for Safety Issues <p><a target="blank" href="http://online.wsj.com/article/SB122063146959204277.html?mod=rss_whats_news_us_business">Wall Street Journal Source</a> <a target="blank" href="http://www.wave3.com/Global/story.asp?S=8961009">Wave 3 Source</a></p> <p> Conference with Gerald...</p> http://www.pharmstatus.com/regulatory/archives/09-01-2008_09-30-2008.html#24 http://www.pharmstatus.com/regulatory/archives/09-01-2008_09-30-2008.html#24 news Fri, 05 Sep 2008 21:16:05 -0700