Clinical trial participants often misunderstand the differences between research and clinical care – a ‘longstanding problem’ that an enhanced informed consent process could diminish, says report.
Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).
The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.
Enhanced clinical trial design legislation proposes an alternative to the Right to Try Act – both of which address the FDA's current compassionate use program.
Celerion has implemented Verified Clinical Trials’ (VCT) biometric fingerprint technology to address “significant amount” of participants dual enrolling at Ph I units.
The Trump administration is looking to massively reduce regulations – which could have major implications for pending guidelines that look to increase clinical trial patient safety.
The HHS issued a final rule updating outdated regulations to provide enhanced protection for clinical research participants – and the FDA may follow suit.
As holidays shoppers wrap up their presents with ribbons and bows, Outsourcing-Pharma.com reviews how contract pharmaceutical packaging companies help ensure successful patient outcomes with iterative design.
Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".
According to a recent study, traditional efficacy trials have limited applicability in everyday clinical practice – an issue which researchers say needs to be amended.
As regulators push the industry to adopt adaptive studies to reduce risk to both patients and manufacturers, the FDA has finalized a guidance outlining key issues and recommendations.
