July 11th 2025
By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
FDA Looks to New Techology, Policies to Streamline Clinical Research
February 1st 2016Agency is asking sponsors to propose demonstration projects that test the use of electronic health records and standards-based technology solutions. Ensuring trials assess new drugs in diverse patient populations is also a priority focus for FDA.
Leveraging Regulatory Science to Succeed at CDRH
December 7th 2015CDRH announced its top 10 Regulatory Science Priorities for Fiscal Year 2016, and stated that these priorities are more than a mere philosophical statement of topics of interest; rather, these priorities are expected to influence CDRH intramural funding decisions.
Pressure Mounts for Increased Trial Data Transparency
November 17th 2015Pharma and biotech companies are working with academics and health care organizations to establish systems for collecting and sharing the results of clinical trials, but they have far to go, according to a recent analysis of industry adherence to data transparency requirements. A report from the non-profit Bioethics International finds that for a group of new drugs approved by FDA in 2012, large pharma companies fell “below legal and ethical standards” for making public information from the relevant clinical trials.
New EU CT Reg: Headway, Concerns
August 26th 2015Approved by the European Parliament in April 2014 is EU Regulation 536/2014, which replaces the decade-old Directive 2001/20/EC – the Clinical Trials Directive. While approved last year, it does not apply earlier than May 28, 2016-leaving interested parties only nine months to prepare for its arrival.
Revised 'Cures' Proposal Seeks to Simplify Clinical Trials, Speed Approvals
May 1st 2015Among the multiple proposals for stimulating drug development and revising regulatory processes, the 21st Century Cures initiative includes several provisions designed to streamline clinical research and the amount of data required to gain FDA approval of certain indications.
FDA’s Expedited Review Process: The Need for Speed
March 11th 2015The FDA works to protect public health by balancing the requirements for extensive safety and efficacy data prior to approval, and the need to expeditiously issue approval decisions to ensure medicines that could save or dramatically improve patients’ lives are available as soon as possible.