Theorem Clinical Research

Ethics/Regulatory

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.

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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.

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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.

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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.

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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.

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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.

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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.

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AAHRPP accredits two organizations in U.S., one in Mexico

Friday, September 19, 2014 01:28 PM

The nonprofit Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited three more organizations, including two independent institutional review boards in Massachusetts and a second organization in Mexico.

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ABPI comments on NICE’s response to value-based assessment consultation

Friday, September 19, 2014 12:50 PM

The National Institute for Health and Care Excellence (NICE) board has considered proposals on value-based assessment (VBA) following a three-month consultation.

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Health advocate coalition says EMA advice for fee undermines independence of regulatory authorities

Monday, September 15, 2014 12:18 PM

Health Action International Europe (HAI Europe), the International Society of Drug Bulletins (ISDB), the Medicines in Europe Forum (MiEF) and the Association Internationale de la Mutualité (AIM) have criticized the EMA for providing confidential “advice” to pharmaceutical companies on their development plans for new medicines in exchange for fees—a potentially harmful practice the EMA now is trying to extend to national health technology assessment (HTA) bodies in the E.U.

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