Clinical Trials
In an ongoing effort to accelerate the commercialization of select innovative drugs and medical devices, Korea’s MFDS is launching a new program for certain products that will receive regular regulatory consultations until they reach the approval stage.
Clinical trial draft guidance webpages are back online following a court order, but with new language disclaiming any information promoting gender ideology as "extremely inaccurate."
The European Medicines Agency is looking for researchers to conduct scientific studies that address specific regulatory concerns, such as the development of innovative clinical trial designs or validation of novel manufacturing methods.
Companies looking to conduct decentralized clinical trials in Europe can now easily see how Switzerland’s rules and processes compare with those of EU member states.
A new depression trial taking place across six European countries to test the safety and efficacy of multiple treatments will initially focus on repurposed drugs approved for other indications. There are plans to expand to Phase III settings and include additional treatments based on stakeholder input.
The Association of Clinical Research Organizations has awarded “seed funding” to seven US-based community clinical trial sites to demonstrate proof-of-concept projects aimed at increasing diversity in clinical trials.
Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader talk about compliance requirements that pharma and global capability centers may need to consider as India strengthens the framework for the protection of digital personal data.
The majority of clinical trials that were approved under the erstwhile Clinical Trials Directive are now governed by the Clinical Trials Regulation. The few that did not transition may be subject to corrective measures by member states.
The US Health and Human Services Secretary nominee’s commitment should be a positive sign for those who want to ensure Americans can access adequate data on drugs in all populations that could use them.
Until the revised international good clinical practice guideline ICH E6(R3) comes into effect in the EU, the Danish regulator advises responsible parties to identify training needs through a gap analysis or other means to ensure compliance.
The Council of the EU has formally adopted the European Health Data Space regulation, meaning that it will soon enter into force in the EU. Experts explain what this means for the pharmaceutical industry.
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.
Several critical FDA drug activities can skirt early Trump administration directives, but trial diversity and health equity work may be hobbled.
In his final days as commissioner, Robert Califf posted thoughts on the COVID-19 vaccine experience and the limited booster uptake, suggesting that a placebo-controlled trial of the next booster update be run to improve confidence and develop better evidence in subgroups.
A six-year project aiming to establish a “less fragmented and more democratic” approach to clinical studies has commenced in the EU.
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.
Prospects are promising for many of the 16 novel candidates that received complete response letters in 2024 after half of the 2023 CRL class was approved the following year.
Faster approvals and regulatory flexibility are among moves India has made to draw clinical trial investments. As MNCs seek to replace products close to patent expiry with new blockbusters and domestic companies tap unmet needs, how will the R&D landscape shape up in 2025?
A working group of EU regulators has developed a comprehensive repository of fee requirements relating to the Clinical Trials Regulation to help sponsors navigate the diverse demands of member states in the European Economic Area.
The MHRA’s new scientific dialog program will offer drug developers “closed-door meetings” that will offer “confidential, commercially sensitive discussion” with its staff to help them “refine” their real-world evidence generation strategies.