Ethics/Regulatory

NHS England consults on plans for a sustainable Cancer Drugs Fund

Tuesday, October 7, 2014 10:00 AM

NHS England is proposing changes to the way its Cancer Drugs Fund (CDF) operates, so that it delivers maximum benefit for patients, within the resources available.

More... »


FDA seeks permanent injunction against Pharmaceutical Innovations

Monday, October 6, 2014 03:46 PM

The FDA is seeking a permanent injunction to stop Pharmaceutical Innovations, and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling and distributing medical products until they come into compliance with all applicable FDA requirements.

More... »


EMA launches new patient-reported suspected side effects web site

Monday, October 6, 2014 03:45 PM

European citizens now can obtain information on suspected side effects, also known as suspected adverse drug reactions, of an additional 1,700 active substances contained in medicines approved in the European Union (E.U.) through a newly launched web site maintained by the EMA.

More... »

FDA takes steps to strengthen cybersecurity of medical devices

Friday, October 3, 2014 11:01 AM

To strengthen the safety of medical devices, the FDA has finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

More... »

EMA to publish clinical reports effective January 2015

Friday, October 3, 2014 10:57 AM

The EMA has decided to publish clinical reports that underpin the decision-making on medicines. Following extensive consultations held by the agency with patients, healthcare professionals, academia, industry and other European entities over the past 18 months, the EMA management board unanimously adopted the new policy Oct. 2. It will apply to clinical reports contained in all applications for centralized marketing authorizations submitted after that date. The reports will be released as soon as a decision on the application has been taken. The policy will enter into force in January 2015.

More... »

Guideline outlines applications for pediatric investigation plans

Thursday, October 2, 2014 02:29 PM

The European Commission (E.C.) has published a revised guideline on applications for pediatric investigation plans, or PIPs, in the Official Journal of the European Union. The new guideline is expected to facilitate the application process. It is intended for all medicines developers.

More... »

Rare Cancers Europe calls for new criteria to be used in clinical trials

Thursday, October 2, 2014 02:26 PM

A consensus paper by Rare Cancers Europe (RCE) calls for new methodologies to be applied to clinical studies in rare cancers. RCE—a multi-stakeholder initiative representing patient associations, medical societies and industry—is calling both the community of researchers and European authorities to address research methodologies and regulatory criteria that could limit rare cancer patient access to new therapies. This would mean discrimination against this patient population.

More... »

CMS makes first wave of open payments data public

Thursday, October 2, 2014 08:27 AM

Centers for Medicare & Medicaid Services (CMS), as part of its ongoing effort to increase transparency and accountability in healthcare, this week released the first round of Open Payments data to help consumers understand the financial relationships between the healthcare industry and physicians and teaching hospitals.

More... »

FDA awards grants to stimulate drug, device development for rare diseases

Wednesday, October 1, 2014 01:27 PM

The FDA has awarded 15 grants totaling more than $19 million to boost the development of medical device, drug and biological products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.

More... »

WIRB Copernicus Group acquires ePharmaSolutions

Wednesday, September 24, 2014 08:00 AM

By Ronald Rosenberg
CenterWatch Staff Writer

WIRB Copernicus Group, after acquiring three IRBs in the past four months, is continuing its spending spree, expanding into a new area with the purchase of ePharmaSolutions (ePS) of Plymouth Meeting, Pa.

More... »

Subscribe to The CenterWatch Monthly
CWWeekly

February 23

Venture capital investors funding novel drug R&D three times more than companies repurposing, improving existing drugs

In appreciation: Karen Woodin will be remembered for her teaching, writing and lasting friendships

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs