Ethics/Regulatory

FDA requests $4.7B budget to ensure safety of food supply, modernize medical product safety

Friday, April 12, 2013 11:41 AM

The FDA is requesting a budget of $4.7 billion to protect and promote the public health as part of the President's fiscal year (FY) 2014 budget. Industry user fees would fund 94% of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA's ability to oversee imported food.

More... »

WIRB Copernicus Group

ABPI to introduce new clinical trial transparency measures

Friday, March 1, 2013 02:42 PM

The Association of the British Pharmaceutical Industry (ABPI) will put in place measures to monitor compliance to the clinical trial transparency provisions contained in the ABPI Code of Practice. An independent, third-party service provider will be appointed to undertake this work, and the ABPI will take on the responsibility for reporting non-compliance with trial registration and posting of summary results.

More... »

CRF Health eCOA webinar series

EMA: Small, medium enterprises see consistent improvement in drug approvals

Friday, March 1, 2013 02:39 PM

Micro, small and medium-sized enterprises (SMEs) registered with the SME office of the European Medicines Agency have seen a consistent improvement in the success rate of their marketing-authorization applications (MAAs) over the past seven years, according to the SME offices’s 2012 annual report.

More... »

OECD urges countries to harmonize clinical trial regulations to boost research, save lives

Tuesday, February 26, 2013 10:33 AM

Increasingly complex and inconsistent clinical trial regulations are causing delays, raising costs and leading to a decline in the number of international trials conducted by academics for non-commerical purposes. In the E.U. alone, the number of applications for clinical trials fell by 25% between 2007 and 2011.

More... »

Sanford Heisler files $100m+ class action complaint against Daiichi Sankyo

Wednesday, February 13, 2013 10:32 AM

Six current and former female pharmaceutical sales professionals have filed a $100 million class and collective action gender discrimination lawsuit against Daiichi Sankyo, the U.S. branch of the Japan-based pharmaceutical company, in the U.S. District Court for the Northern District of California.

More... »

Court shuts down U.S. operations of Titan Medical Enterprises

Monday, February 11, 2013 02:56 PM

A federal judge has ordered Titan Medical Enterprises, a Santa Fe Springs, Calif.-based manufacturer, and its owner, James L. McDaniel, to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act.

More... »

FDA offers new guidance on developing drugs for Alzheimer's

Friday, February 8, 2013 11:47 AM

The FDA has issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable dementia.

More... »

GVB BIO licenses biomarker database to FDA

Thursday, February 7, 2013 08:00 AM

GVK Biosciences, a discovery, research and development organization providing a broad spectrum of services, is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the FDA. The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the FDA in its Biomarker Qualification Process.

More... »

Almac’s new U.S. commercial packaging operations pass FDA inspection

Wednesday, February 6, 2013 09:16 AM

Global service provider Almac has passed FDA inspection of its new U.S. commercial packaging operations located in Audubon, Penn. The inspection took place on Jan. 9 and 10, 2013, from which the regulatory body concluded that the site is fully compliant with Good Manufacturing Practices, with no 483 issued.

More... »

European Medicines Agency to focus on efficiency, transparency in 2013

Thursday, January 10, 2013 02:21 PM

The European Medicines Agency’s management board has adopted the agency’s work program and budget for 2013, with priorities continuing to be ensuring assessment activities are conducted to the highest scientific levels, increasing efficiency in its activities and developing initiatives for greater transparency and communication with stakeholders.

More... »

Subscribe to The CenterWatch Monthly
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

July 21

As job growth in drug development sector soars, more employees are seeking new opportunities

U.K. study: Prisoners should have the right to participatein clinical trials on moral grounds, for healthcare access

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

Already a subscriber?
Log in to your digital subscription.

Purchase the July issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

June

CRO market poised for growth and consolidation
Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

Strategies for success evolving in phase I space
Sites see increasing complexity, more patients, greater focus on efficacy

Already a subscriber?
Log in to your digital subscription.

Purchase the June issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs