The latest Regulatory Affairs News & Drug Approvals News articles published daily. Includes news on FDA approvals, EMEA approvals and other regulatory issues. News: Regulatory and Drug Approvals News - 12 Jun 08, 9:18pm -
The FDA is announcing the availability of the draft guidance entitled 'Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.' This draft document provides CDRH's proposed interpretation… - 3 days ago, 17 May 13, 4:00am -
This document has the following purposes: (1) develop a common understanding of the statutory criteria for granting expedited review to premarket submissions for medical devices, and (2) outline standard procedures that should be followed to achieve… - 3 days ago, 17 May 13, 4:00am -
The FDA is announcing the availability of the guidance entitled 'Center for Devices and Radiological Health (CDRH) Appeals Processes.' This document describes the processes available to outside stakeholders to request additional review of d… - 3 days ago, 17 May 13, 4:00am -
The cobas® EGFR Mutation Test is an automated molecular assay designed to detect the presence of mutations in the epidermal growth factor receptor (EGFR) gene in cancer-spreading (metastatic) non-small cell lung cancer (NSCLC). - 3 days ago, 17 May 13, 4:00am -
Meeting materials posted for May 21-22, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting - 3 days ago, 17 May 13, 4:00am -
Labeling, Approval Order, and Summary of Safety and Effectiveness for VASCADE Vascular Closure System (VCS) (P120016). - 3 days ago, 17 May 13, 4:00am -
This draft guidance document provides CDRH proposed interpretation of key provisions of Section 517A of the Food, Drug and Cosmetic Act (FD&C Act), which was added by section 603 of the FDA Safety and Innovation Act (FDASIA) of 2012, as those provisi… - 4 days ago, 16 May 13, 4:00am -
The FDA classifying the ingestible event marker into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. - 4 days ago, 16 May 13, 4:00am -
This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. - 4 days ago, 16 May 13, 4:00am -
The North Chicago, IL-based drug giant and Belgium's Galapagos have agreed to expand their collaboration on an oral JAK1 inhibitor to include Crohn's disease. - 2 days ago, 17 May 13, 3:34pm -
In a Friday announcement, Novo Nordisk said it completed the first phase III trial of its drug N9-GP for hemophilia B patients. - 2 days ago, 17 May 13, 3:32pm -
Sanofi can't shake the underproductive R&D site in Toulouse, France, without a fight from workers and French government officials. In the latest chapter of the ongoing feud, the Paris-based drug giant and a familiar critic in France's government show… - 2 days ago, 17 May 13, 2:34pm -
More biotech companies are forging academic partnerships as they downsize their internal R&D efforts, and another outfit to ride that wave is Germany's Evotec AG. Evotec will collaborate with Harvard University to hunt for and develop new anti-bacter… - 2 days ago, 17 May 13, 2:33pm -
Two more biotech outfits emerged this week as contenders to complete initial public offerings, highlighting the open season for the deals this year. Bluebird bio and PTC Therapeutics has mounted campaigns to go public with pipelines that target the m… - 2 days ago, 17 May 13, 1:39pm -
The pivotal study for SAR302503 nailed the primary endpoint for the proportion of patients with a greater than 35% reduction in the volume of their spleens, which become enlarged as a result of abnormal blood cell production. - 3 days ago, 17 May 13, 12:26pm -
Bristol-Myers Squibb has emerged, at least temporarily, as the leader in a race to develop the first new PD-1 drug to fight cancer. - 3 days ago, 16 May 13, 1:50pm -
The biotech sold a bit more than 8 million shares at the reduced price, rather than the 4.6 million shares it had intended. - 3 days ago, 16 May 13, 12:56pm -
NEW YORK (AP) — Scientists have finally recovered stem cells from cloned human embryos, a longstanding goal that could lead to new treatments for such illnesses as Parkinson's disease and diabetes. - 4 days ago, 15 May 13, 4:40pm -
By Sharon Begley NEW YORK (Reuters) - After more than 15 years of failures by scientists around the world and one outright fraud, biologists have finally created human stem cells by the same technique that produced Dolly the cloned sheep in 1996: The… - 4 days ago, 15 May 13, 4:09pm -
It’s been 17 years since Dolly the sheep was cloned from a mammary cell. And now scientists applied the same technique to make the first embryonic-stem-cell lines from human skin cells. - 4 days ago, 15 May 13, 4:00pm -
The Food and Drug Administration on Tuesday approved a genetic test from Roche to help doctors identify patients who can benefit from a lung cancer drug made by the company's Genentech unit. The diagnostic ... - 5 days ago, 14 May 13, 9:19pm -
(Reuters) - U.S. health regulators on Tuesday approved a test developed by Roche for a specific gene mutation present in about 10 percent of non-small cell lung cancers, and said the company's drug Tarceva could be used as an initial treatment in pat… - 5 days ago, 14 May 13, 9:13pm -
BOISE, Idaho (AP) — A dozen years after a customer revolt forced Monsanto to ditch its genetically engineered potato, an Idaho company aims to resurrect high-tech spuds. - 5 days ago, 14 May 13, 6:27pm -
BREAKTHROUGH: A new genetic test to gauge the aggressiveness of prostate cancer may help men decide whether they need to treat their cancer right away or can safely monitor it. PROVIDING ANSWERS: Doctors ... - 11 days ago, 8 May 13, 4:11pm -
A new genetic test to gauge the aggressiveness of prostate cancer may help tens of thousands of men each year decide whether they need to treat their cancer right away or can safely monitor it. - 11 days ago, 8 May 13, 1:57pm -
LONDON (AP) — Olympic officials and scientific experts will meet in China next month to review the progress in developing a test for gene doping, the potential future of cheating in sports. - 17 days ago, 3 May 13, 10:34am -
A federal judge displayed anger as she handed down a four-year prison sentence Thursday to a biotechnology financier who was once among the nation's wealthiest people. U.S. District Judge Colleen McMahon ... - 17 days ago, 3 May 13, 12:35am -
The European Medicines Agency has overhauled its overarching guideline on biosimilars, bringing it up to date and clarifying the principles and terminology of biosimilarity1,2. The revised document says that in some..... - 3 days ago, 16 May 13, 3:55pm -
If ever anyone wanted to "screw up a safety study," GlaxoSmithKline's RECORD trial, which assessed cardiovascular outcomes after the addition of Avandia (rosiglitazone) to either metformin or sulfonylurea, "was the perfect..... - 10 days ago, 10 May 13, 6:21am -
The US Department of Justice on 1 May filed a notice of appeal with the US Court of Appeals for the Second Circuit seeking to get overturned a 5 April ruling directing the Food and Drug Administration to make ..... - 16 days ago, 3 May 13, 2:18pm -
European filers of medical device patents, those in the UK in particular, have two potential reasons to look the future with optimism, according to Simon Cooper, director and attorney at patent and trademark firm AdamsonJones. ..... - 25 days ago, 25 Apr 13, 7:15am -
MEPs on the European Parliament's environment and public health (ENVI) committee have decided to postpone their vote on the draft clinical trials regulation, which was due to be held on 24 April but will now take place on 29 May. - 27 days ago, 22 Apr 13, 2:05pm -
The Court of Justice of the EU has dismissed Italy and Spain's challenges against the new EU patent system1, but Spain is not giving up easily and is pursuing a further two actions that will give the patent's ..... - 31 days ago, 19 Apr 13, 6:25am -
Dominique Maraninchi, the director general of the French medicines agency, the ANSM, has appeared before judges to answer questions relating to the agency's role in the Mediator drug affair, the agency has confirmed. The judges..... - 55 days ago, 26 Mar 13, 7:39am -
Did you read Scrip Regulatory Affairs' coverage of the most business-critical developments in EU medical device regulatory affairs in 2012? Here, for your convenience, are some of the most-read articles in this..... - 23 Jan 13, 2:52pm -
Did you read Scrip Regulatory Affairs' coverage of the most business-critical developments in US medical device regulatory affairs in 2012? Here, for your convenience, are some of the most-read articles in this area on - 23 Jan 13, 2:51pm -
Did you read Scrip Regulatory Affairs' coverage of the most business-critical developments in medtech regulatory affairs outside the US and EU in 2012?Here, for your convenience, are some of the most-read articles in..... - 23 Jan 13, 2:50pm -
WASHINGTON--(BUSINESS WIRE)--The Biotechnology Industry Organization thanks Rep. Tim Walz of Minnesota for offering an amendment to the House Farm Bill that would provide mandatory funding to Energy Title programs. - 3 days ago, 16 May 13, 2:30pm -
WASHINGTON--(BUSINESS WIRE)--The Biotechnology Industry Organization (BIO) today lauds the House of Representatives for passing H.R. 701, a bill to speed the implementation of a key capital formation provision in the Jumpstart Our Business Startups (… - 3 days ago, 16 May 13, 2:11pm -
WASHINGTON--(BUSINESS WIRE)--The Biotechnology Industry Organization (BIO) today thanks Representative David Schweikert (R-AZ) for introducing H.R. 1952, the Spread Pricing Liquidity Act. H.R. 1952 is designed to increase liquidity and spur capital f… - 4 days ago, 15 May 13, 1:39pm -
WASHINGTON--(BUSINESS WIRE)--The Farm Bill energy programs will continue to create jobs. Michigan biotech industry joins the national organization in support of the Senate Farm Bill. - 5 days ago, 15 May 13, 1:01am -
WASHINGTON--(BUSINESS WIRE)--The draft Farm Bill to be debated by the Senate Ag Committee on Tuesday, May 14 provides long-overdue eligibility for renewable chemicals to participate in USDA energy programs. - 9 days ago, 10 May 13, 9:37pm -
WASHINGTON--(BUSINESS WIRE)--The Biotechnology Industry Organization (BIO) and the ViS Research Institute (ViS) announce a new initiative aimed at improving the efficiency of clinical development for pediatric therapeutics. BIO and its member compani… - 12 days ago, 7 May 13, 3:00pm -
WASHINGTON--(BUSINESS WIRE)--BIO and its member companies are asking Congress to provide mandatory funding for Farm Bill energy programs and eligibility for renewable chemicals - 16 days ago, 3 May 13, 1:03pm -
WASHINGTON--(BUSINESS WIRE)--BIO expressed concern over the failings of India, China, Brazil and Canada to provide adequate IP protection for biotech companies creating novel and innovative products. - 17 days ago, 2 May 13, 8:48pm -
WASHINGTON--(BUSINESS WIRE)--In response to the House Energy & Commerce Committee white paper on the RFS and agricultural impacts, BIO argued that oil prices have a more deleterious impact, that the RFS was adopted to address - 19 days ago, 30 Apr 13, 1:50pm -
CHICAGO--(BUSINESS WIRE)--The 2013 BIO International Convention, the global event for biotechnology, wrapped up today at McCormick Place in Chicago, Ill. with a record number of partnering meetings and panel sessions on the latest science, policy iss… - 24 days ago, 26 Apr 13, 3:48am -
It has been a busy May. From working in the yard to transform it from looking like property on which Boo Radley might have a house to putting on panel discussions and layers of business travel to grading papers and … Continue reading → - 2 days ago, 17 May 13, 6:10pm -
Many may recall that in early April, I released a paper I did here on Eye on FDA called “FDA Communications Oversight in a Digital Era” that examined the patterns of enforcement by FDA’s Office of Prescription Drug Promotion as … Continue rea… - 6 days ago, 13 May 13, 1:27pm -
The grass is not greener on my side, mainly because it is mostly not there. The lawn, if you want to call it that, looks like it needs a lot of attention – probably more than I have to give … Continue reading → - 16 days ago, 3 May 13, 5:10pm -
It may seem that I write a lot about the letters that FDA puts out regarding industry promotion and communication, but that is exactly what the nature of this blog is about. Other things can be interesting, particularly policy developments, … Conti… - 18 days ago, 1 May 13, 3:12pm -
The spring clothes are headed to the closet, while the winter clothes are headed to their space for their seasonal slumber until next Fall. The days are sunny. The winter mess in the yard has been cleared away (mostly) and … Continue reading → - 23 days ago, 26 Apr 13, 7:55pm -
It has been a really busy week with travel and work that last Friday I didn’t even get to the Weekly Roundup. The schedule has been so busy, leaving no spare time for either posting here on the blog or … Continue reading → - 30 days ago, 19 Apr 13, 1:16pm -
In the wake of publishing “FDA Communications Oversight in a Digital Era” in last week’s blog post, I have been asked some interesting questions. One of them sought to know whether there was a difference between the types of violations … Co… - 38 days ago, 11 Apr 13, 2:43pm -
The daffodils are up and being rounded up in bunches and slipped into vases around the house, spreading good cheer, but overall Spring is still seemingly quite shy though indications are that is about to change. It is perhaps a … Continue reading… - 44 days ago, 5 Apr 13, 3:37pm -
I have been working to assemble a data base of FDA/OPDP Warning and NOV letters spanning the years 2004-present, tracking activity through a number of fields. The database now includes hundreds of letters and covers nearly 1000 violations cited… - 48 days ago, 2 Apr 13, 11:06am -
Fri, 04/26/2013 FDA The Center for Devices and Radiological Health (CDRH) issued an update this week on its efforts towards strengthenin… - 13 days ago, 6 May 13, 4:43pm -
Tue, 04/09/2013 Health Care Reform, Device Tax WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers As… - 40 days ago, 9 Apr 13, 6:39pm -
Thu, 03/21/2013 Health Care Reform, Device Tax Vote Underscores Bipartisan Support for Device Tax Repeal EffortsWashington, D.C. – Th… - 59 days ago, 22 Mar 13, 11:51am -
Tue, 02/26/2013 Health Care Reform, Device Tax WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers Ass… - 82 days ago, 26 Feb 13, 4:56pm -
Mon, 02/18/2013 Patent Reform The U.S. Patent & Trade Office (USPTO) recently published final rules and guidance implementing the first… - 83 days ago, 25 Feb 13, 5:46pm -
Tue, 02/12/2013 Health Care Reform, Device Tax WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers As… - 95 days ago, 13 Feb 13, 4:34pm -
Thu, 02/07/2013 Health Care Reform, Device Tax Washington, D.C. – A coalition of medical device manufacturers today applauded Member… - 7 Feb 13, 9:19pm -
Wed, 02/06/2013 Health Care Reform, Device Tax WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers As… - 6 Feb 13, 8:10pm -
