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Over four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on justifying starting materials for chemical entity drug substances. Read More
The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics. Read More
An early OMB blueprint for the president’s fiscal 2018 budget request looks to transfer $54 billion from non-defense programs and agencies, including the FDA, to the military. Read More
In his first address to Congress, President Trump called for faster and more frequent drug approvals, and labeled the FDA’s review process as “slow and burdensome.” Read More