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Cutting the costs of clinical trials, developing tools to improve clinical trial enrollment and filling gaps in antibacterial drug development were named as major priorities in the FDA’s fiscal 2018 budget proposal. Read More
The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure May 15, including a new Office of Bioresearch Monitoring Operations that will work with each of the FDA’s product centers to ensure subject protection in clinical studies. Read More
The Australian Therapeutic Goods Administration issued an industry guidance proposing to quickly approve certain types of low-risk variations to registered medicines without requiring evaluation, allowing sponsors to implement the changes immediately. Read More
Two-thirds of the way through fiscal year 2017, the FDA has received at least 877 ANDAs, passing fiscal 2016’s total of 852 and beating fiscal 2015’s total by more than 330 applications. Read More
The European Medicines Agency has decided to postpone the implementation of its Clinical Trials Regulation from October of next year to 2019 at the earliest, due to technical difficulties. Read More
Nevada’s landmark plan requiring insulin manufacturers to disclose price information was signed into law last week, establishing a more targeted strategy compared to the broader price transparency legislation currently being pursued in other states. Read More
PhRMA, BIO and The Pew Charitable Trusts have banded together to ask Congress to include language in the fiscal 2018 appropriations bills to clarify the FDA’s power to regulate compounding pharmacies. Read More
The FDA highlighted two fictional case studies it published on the role biomarker qualification plays in drug development — as part of a reorganization of the agency’s biomarker materials — to help drugmakers understand the validation studies necessary to support qualification, the collaborative efforts involved and the potential benefits. Read More