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…
The FDA’s Office of Pharmaceutical Quality is working to rebalance views on measuring risks versus benefits, as well as improve the effectiveness of the agency’s communications to industry and the…
An FDA advisory committee voted unanimously to recommend to the agency that a diabetic drug is not associated with excessive cardiovascular risk, and also voted 17-to-2 to recommend an added…
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and…
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…
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. Source: Drug Industry Daily
Amid a firestorm of controversy surrounding Mylan’s EpiPen, the FDA has approved an alternative. Source: Drug Industry Daily
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. Source: Drug Industry Daily
The FDA is proposing to shorten ANDA review timelines for certain generics sponsors that submit advance information to the agency. Source: Drug Industry Daily
Drugmakers now have the option of filing the FDA’s Field Alert Report (FAR) form online, following a successful four-year pilot program. Source: Drug Industry Daily