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April 2014

Vol. 19
No. 4


EU Backing Off of CCI In Trial Report Transparency

EU officials continued to show their willingness to meet drugmakers halfway on new plans for publication of clinical trial reports. Read More

FDA Presses Broader Use of Bayesian Methods in Phase II, but Not Phase III

While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies. Read More

Sponsors Must Justify Excess Drugs in Injectable Products

Sponsors of BLAs, NDAs, and ANDAs should justify the amount of excess medication for injectable drug products they plan to pack in vials and ampules, according to an FDA draft guidance. Read More

InterMune Goes it Alone After AbbVie Drops EMA Lawsuits

Shortly after the EMA announced it would consider redacted clinical trial reports in its proposed transparency plan, AbbVie said it was dropping two lawsuits against the agency. Read More

EMA Updates Assessment, Acceptance Criteria in Final ITP Guidance

The European Medicines Agency has backed off of several controversial limitations it was considering imposing on sponsors of trials for treatments for chronic primary immune thrombocytopenia. Read More

FDA Urged to Use ‘Carrot and Stick’ Approach to Boost Subgroup Research

The FDA should incentivize sponsors to include minorities and other underrepresented groups in clinical trials and delay approving products whose evidence is based on less-inclusive trials, activists say. Read More

Sponsors See Inconsistency in FDA’s Push for More Safety Data for Painkillers

Drugmakers balked at the FDA’s push for sponsors of new chronic pain treatments to submit more safety data, calling it inconsistent and confusing. Read More

Two Definitive Trials May Be Sufficient for CFS/ME Drugs

Supportive data gathered from two definitive clinical trials may be sufficient to establish efficacy for drugs proposed to treat chronic fatigue syndrome/myalgic encephalomyelitis, the FDA says. Read More

FDA Warning Targets Investigator, Despite Institutional Action

FDA inspectors berated a clinical investigator at New York’s Columbia University Medical Center for failing to properly oversee a clinical trial, despite the university having shut down the study after discovering the violations. Read More

FDA Urges Sponsors to Conduct PK Studies to Show BA/BE

The FDA is asking sponsors of INDs, NDAs and NDA supplements to submit bioavailability and bioequivalency data from pharmacokinetic studies of their products. Read More

EMA ‘Adaptive Licensing’ Pilot Could Speed Access to New Drugs

The European Medicines Agency last month launched a pilot program to speed new therapies to patients by authorizing products in stages for targeted populations. Read More