MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'gmp'. Sat, 03 Sep 2011 02:48:36 +0100 http://www.medworm.com/index.php?rid=4911824&cid=t_103860_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAutTWJ-YZYs%2F Faced with growing challenges in clinical trials, manufacturing and drug safety - among many other issues - the FDA has decided to elevate the Office of Compliance to a so-called Super Office on a par with others in the Center For Drug Evaluation and Research, such as the Office of New Drugs, the Office of Pharmaceutical Science and the Office of Surveillance and Epidemiology. The responsibilities will include ensuring compliance with requirements for good manufacturing practice, good clinical practice, human subject protection, adverse event and drug quality reporting, REMS, drug labeling, drug approval, drug importation, and supply chain integrity, among others, according to a memo from CDER director Janet Woodcock. And the new super compliance office will also have three officewide func... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911824 Tue, 07 Jun 2011 12:06:07 +0100 4911824 http://www.medworm.com/index.php?rid=4627018&cid=t_103860_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGDgziD-nSo4%2F If you are a drugmaker with a poor track record of complying with so-called Good Manufacturing Practices, the FDA wants you to know that you are more likely to be targeted for further scrutiny. And to make good on this promise, an FDA official says the agency is developing better ways to track manufacturer compliance in order to more efficiently focus investigations, FDA News writes. The FDA must “be able to shift our resources to the high-risk areas, which means the high-risks firms. We should be looking at those companies with a history of non-compliance. They deserve more scrutiny, and they will have more scrutiny. And we are looking at ways to better track a company’s history over time,” FDA associate commissioner for regulatory affairs Dara Corrigan told the International G... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627018 Wed, 23 Mar 2011 15:35:28 +0100 4627018 http://www.medworm.com/index.php?rid=4277958&cid=t_103860_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxWGxZrIn9t4%2F As promised, a handful of House Democrats have introduced legislation that would increase funding and authority for the FDA to monitor drug production - both domestically and overseas - in hopes of improving safety in the wake of the Heparin scandal and other recent episodes that questioned foreign production of meds sold in the US. The bill would crreate an up-to-date registry of all domestic and foreign facilities serving the US; generate funding for increased Good Manufacturing Practices (GMP) inspections for brand and generic drugs; require parity between foreign and domestic inspections; prohibit entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections; prohibit drugs from entering the US if safety documentation is lacking; requires manufact... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4277958 Tue, 21 Dec 2010 14:38:54 +0100 4277958 http://www.medworm.com/index.php?rid=4125280&cid=t_103860_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfB8CHD15wQY%2F In a scathing report, the US General Accountability Office has determined that the FDA failed to implement earlier recommendations that would close the gap between the agency’s approach to inspecting domestic and foreign drug manufacturing facilities. Consequently, the GAO writes that it is unclear if steps being taken by FDA “will prove successful” and there is an “urgent need” to better protect public health by putting GAO suggestions into practice. Here are some key findings: The FDA boosted its budget for foreign inspections to $41 million in fiscal 2009 compared with $12 million in fiscal 2008 and $10 million in fiscal 2007, and increased the number of foreign inspections. In fiscal year 2009, for instance, the FDA conducted 424 foreign inspections, compa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4125280 Mon, 01 Nov 2010 15:29:16 +0100 4125280 http://www.medworm.com/index.php?rid=3706993&cid=t_103860_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNJj_HyWGF4o%2F In what may be a new get-tough program at the FDA, the agency issued a so-called untitled letter to CSL, a big maker of flu vaccines based in Australia, for flunking an April inspection that found several manufacturing deficiencies. And in addition to demanding a summary of corrective actions that must be taken, FDA officials want to meet with CSL senior execs to review their plan. The move comes less than a month after CSL recalled its seasonal shot for children in Australia after investigations failed to explain a nine-fold increase in fever and convulsions. However, the FDA also issued a Q&A in which the agency says the manufacting issues are unrelated to the problems that spurred the recall (background here and here). The FDA cited CSL for “a number of significant objectio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3706993 Mon, 28 Jun 2010 20:42:34 +0100 3706993 http://www.medworm.com/index.php?rid=1871107&cid=t_103860_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F416685128%2F The US Department of Justice has dropped legal action against Ranbaxy after the Indian generic drugmaker agreed to provide long-sought audits, which may shed light on allegations that falsified records resulted in the production and sale of generic meds that failed to meet FDA standards (back story and latest court filing). The move appears to end a stalemate that last July prompted the US Attorney in Maryland to force Ranbaxy to release the audits, which were conducted by Parexel and that Ranbaxy claimed were privileged information. In the interim, the FDA banned nearly 30 Ranbaxy meds from entering the US after the FDA cited two Indian plants for inadequate controls and procedures. The hoopla recently prompted the President’s Emergency Plan for AIDS Relief, or PEPFAR, which buys meds f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1871107 Fri, 10 Oct 2008 10:55:12 +0100 1871107 http://www.medworm.com/index.php?rid=1802933&cid=t_103860_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F394807694%2F The agency is getting tougher with the generic drugmaker, which is already cited by federal prosecutors for allegedly falsifying records that resulted in the production and sale of meds failing to meet FDA standards. Now, the FDA has issued warnings letters and an import alert for more than 30 meds made at two plants in Dewas and Paonta Sahib in India. The agency, which has been investigating Ranbaxy since 2005, cites deviations from Good Manufacturing Practices and, as a result, federal authorities have the right to detain at US borders any Ranbaxy drugs and active pharmaceutical ingredients made at those facilities (this is the list of products). In explaining the action, FDA officials call the move “proactive,” but stressed they are not removing Ranbaxy products from the ma... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1802933 Tue, 16 Sep 2008 18:56:05 +0100 1802933 http://www.medworm.com/index.php?rid=1652562&cid=t_103860_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F344544924%2F The impetus would be the different requirements for scaling up for clinical trials and commercial manufacturing, according to in-PharmaTechnologist, which adds that the FDA’s new regulatory guidance removes the requirement that candidate drugs are produced using a fully validated manufacturing process. The ruling, which goes into effect on September 15 and will apply to most candidate biologics, small molecules and vaccines, also removes some of the stock rotation requirements and labelling regs that are applied to drugs produced on a commercial scale, the trade reports, according to in-Pharma. Drugmakers must still comply with statutory current GMP guidelines and submit detailed info about production processes as part of an IND, or investigational new drug application, but the new ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1652562 Thu, 24 Jul 2008 12:23:17 +0100 1652562 http://www.medworm.com/index.php?rid=1314172&cid=t_103860_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F03%2Fsurpise-ingap-moves-ahead.html Remember INGAP? Well, the quick overview is that INGAP stands for Islet Neogenesis Associated Protein. I noted it in a posting back in January when I reported that researchers at the University of Florida had announced findings from a study involving the use of proteins as a potential therapy for type 1 diabetes which accomplished something remarkably similar to INGAP -- in their case, the protein Pdx1 or simply PDX stimulated new islet growth. INGAP appears to incent Pdx1 production. More details on the INGAP story is chronicled here for reference:Spring 2002Winter 2002Summer 2003Spring 2004Fall 2006The SPIRIT Research ProgramUpdate on the SPIRIT Research ProgramINGAP has something of a checkered history. Although it appears promising, the rights to commercialize it have traded hands a nu... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1314172 Wed, 19 Mar 2008 17:30:00 +0100 1314172 http://www.medworm.com/index.php?rid=482202&cid=t_103860_118_f&fid=34973&url=http%3A%2F%2Fmed-biz-wiz.livejournal.com%2F9691.html This is not a top-level strategic post about how to think about your business, instead I want to discuss implementation of operational management of product development in compliance with some FDA and international standards for medical device development. Why? If your company develops product, and does it slower than your competition by even one percent, then you are slowly losing. Remember that the house advantage in roulette is only 1%, but the casinos love to have those table -- so don't create internal systems that will slow you down un-necessarily. You have to be compliant in this business, but you don't have to be stupid. So let's talk about design control.Design control is the name of this process in ISO and FDA documents, but that is a complete misnomer. The new ISO 13485 calls th... unAudited blogs http://www.medworm.com/rss/comments.php?id=482202 Thu, 12 Jan 2006 15:21:30 +0100 482202