Theorem Clinical Research

Ethics/Regulatory

PHT launches FDA Roadmap App for patient-focused outcome measurement

Wednesday, March 26, 2014 11:44 AM

Launched by PHT, a provider of technologies used to collect patient-driven eData for clinical research, the new FDA Roadmap App is the first mobile app designed to help sponsors navigate the Roadmap to Patient-Focused Outcome Measurement in Clinical Trials, released by the FDA in conjunction with its Clinical Outcome Assessment Qualification Program. The program and roadmap highlight the process by which a sponsor should consider, choose and/or develop a patient-focused outcome measurement strategy in a clinical program.

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European Medicines Agency launches adaptive licensing pilot project

Thursday, March 20, 2014 01:03 PM

The EMA is inviting companies to participate in its adaptive licensing pilot project. Interested companies should submit ongoing medicine development programs for consideration as prospective pilot cases.

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U.K. forms early access to medicines scheme

Monday, March 17, 2014 01:41 PM

The U.K. government has announced a new scheme that aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization.

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vfa CEO responds to German pharmaceutical policy changes

Monday, March 3, 2014 12:46 PM

The German Bundestag is implementing a number of pharmaceutical policy changes within the scope of the 14th law amending Book V of the German Social Code, including an extension of the drug price freeze to 2017.

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U.S., India sign cooperation statement

Thursday, February 27, 2014 12:24 PM

According to the Press Information Bureau of the Indian government, the FDA and India’s Ministry of Health and Family Welfare have signed a Statement of Intent on Cooperation in the Field of Medical Products.

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EMA, FDA collaborate on medicines safety

Friday, February 21, 2014 03:31 PM

The EMA and FDA, which respectively regulate drugs in the E.U. and U.S., have announced a new pharmacovigilance “cluster” to provide a forum to share information on the safety of medicines.

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Regulatory update on India clinical research approval timelines

Wednesday, February 5, 2014 01:26 PM

Dr. Renu Razdan, vice president, ACRO India, and also chief operating officer, CRO Max Neeman Medical International, said he welcomes the new timelines and guidelines set up by the Drug Controller General of India [DCGI] for approval of clinical trials.

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Report: EMA finds increase in rare disease medicines

Monday, February 3, 2014 10:19 AM

A total of 11 out of 81 medicines recommended for marketing authorization by the EMACommittee for Medicinal Products for Human Use (CHMP) in 2013 were intended for the treatment of rare diseases. This continues the year-on-year increase in the number of marketing authorization recommendations for medicines for rare diseases observed over the last few years (with eight in 2012 and four in 2011).

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New Breakthrough Therapy Designation shows potential to shorten drug development time

Wednesday, January 29, 2014 01:04 PM

The Breakthrough Therapy Designation (BTD) program, launched nearly 18 months ago by the FDA and aimed at expediting development and review of drugs intended to treat a serious condition, has the potential to shorten development time considerably, according to the Tufts Center for the Study of Drug Development (Tufts CSDD), which recently completed an assessment of the BTD program.

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FDA launches advisory committee membership nomination portal

Wednesday, January 22, 2014 12:56 PM

The FDA has launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees. 

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