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The FDA hit Tianjin-Jingye Fine Chemicals with a Form 483 for 14 violations, ranging from inappropriate re-injection and outdated stability research to lack of hand-washing facilities. Read More
Sales of orphan drugs are expected to increase by 11 percent and account for 21 percent in the global prescription drug market over the next five years. Read More
International generic drug regulators have published a report template for biowaiver assessments to better reconcile varying biowaiver requirements among regulatory authorities. 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
A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data integrity. Read More
Three drugmakers have filed amicus briefs in support of Regeneron and Sanofi’s efforts to reverse a district court ruling that validated Amgen patents on Repatha and barred the companies from selling their cholesterol drug Praluent. Read More