Lupin hires former nemesis at FDA, how Baker exposed Hisun’s ‘full investigation,’ Cetylite’s many methods for overcoming OOS results, old school inspection-driven recalls at Vitae Enim Vitae Scientific and a critique of Catalent filling line’s non-deliberate response to the pandemic.
Although it may be a common career path to advise the pharmaceutical industry on quality as a consultant or employee after providing free advice for years as a US Food and Drug Administration enforcement official, it’s still rather striking when such an official pens a blistering warning letter, then a year later joins the company.
But that’s what happened with Lupin Limited, whose new employee has a head start on knowing what the problems...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
