International
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
The Australian Therapeutic Goods Administration proposed a narrower indication that Eisai rejected.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.
Pharma industry representative at the ICH expert working group that drew-up the new international good clinical practice standard is advising trial sponsors to focus on proportionality and a risk-based approach throughout their trial design, conduct, analysis and reporting.
The EU’s new Product Liability Directive will make it easier for European consumers to seek compensation relating to defective products even if manufacturers are based outside the bloc. Legal experts caution that this could have substantial implications for pharmaceutical companies.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
The International Generic and Biosimilar Medicines Association has introduced its first global intellectual property and competition report, addressing the urgent need to reform current regulations. But, in a bid to increase access to medicines across the world, did it stop short at just IP and patents?
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The World Health Organization (WHO) has launched an initiative to highlight the pressing global need to reduce the impact of the pharmaceutical industry on the environment while maintaining high standards of safety and efficacy for products.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Modernized good clinical practice principles finalized by the International Council for Harmonisation focus on fostering a quality culture, proactively designing quality into trials, identifying factors critical to trial quality, engaging interested parties, and using a proportionate risk-based approach.
Health technology assessment bodies in England, the US, Canada, Australia, the Netherlands and Colombia have joined forces to produce guidance for drug developers on using surrogate endpoints for cost-effectiveness analyses.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Final guidance on remote and hybrid good manufacturing practice inspections from the global inspectorate body, the PIC/S, aims to enhance inter-agency communication, improve reliance on inspections and ensure efficient use of global resources.
Clinical trial sponsors should strive to strike a balance between privacy and transparency at the very beginning of a trial to be successful, advises Certara’s Honz Slipka.
Two transparency experts share best practices for writing clinical study reports to protect patient privacy.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
International regulators want developers of new mpox vaccines to consider alternatives to placebo-controlled studies when these are not feasible, such as the use of animal models and immunobridging studies.