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China has joined the ICH as its eighth regulatory member, pledging to gradually transform its pharmaceutical regulatory authorities, industry and research institutions to implement the international coalition’s technical standards and guidelines. Read More
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting. Read More
The FDA will clear its backlog of orphan drug designation requests in the next 90 days, Commissioner Scott Gottlieb told Senate appropriators, and the agency plans to assign a team dedicated to assessing the approximately 200 applications currently pending. Read More
The FDA needs to receive $1.2 billion between 2018 and 2022 to make possible the changes presented in the user fee reauthorization bill currently before Congress. Read More
The FDA is seeking feedback on its 2014 compounder registration guidance in the wake of calls for clarification of the differences between traditional and outsourcing compounders. Read More