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FDA hit Tianjin-Jingye Fine Chemicals with a Form 483 for 14 violations, ranging from inappropriate re-injection and outdated stability research to lack of hand-washing facilities. Source: Drug Industry Daily
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. Source: Drug Industry…
International generic drug regulators have published a report template for biowaiver assessments to better reconcile varying biowaiver requirements among regulatory authorities. Source: Drug Industry Daily
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. Source: Drug Industry…
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.” Source: Drug Industry Daily
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…
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…
The World Health Organization has released a draft update to its guidelines for API and finished drug stability testing, that says it reflects how stability testing has evolved since the…
Despite the Senate defeat of a measure allowing drug importation just a month ago, House and Senate Democrats are trying again: they’ve introduced new legislation that would allow imports of…
Pfizer’s Hospira is drawing scrutiny from the FDA in a warning letter for failing to fully investigate quality defects, such as the presence of cardboard, in batches of injections and…