The US Food and Drug Administration (FDA) has released a new draft guidance as part of its stated commitment to assist sponsors and expedite drug development for rare pediatric diseases.
WIRB Copernicus Group (WCG) has expanded its portfolio of companies to include the pharmacovigilance and drug safety solution provider Vigilare International.
As the industry continues to externalize components of the supply chain, global regulatory authorities are requiring a “quality-by-design” (QbD) approach to help mitigate risk across the drug development process.
ICON and the International Consortium for Health Outcomes Measurement's (ICHOM) pilot patient outcomes platform – known as ‘Globe’ – aims to improve drug development procedures.
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The HHS issued a final rule updating outdated regulations to provide enhanced protection for clinical research participants – and the FDA may follow suit.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.
