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Latest From Joanne Eglovitch
FDA’s expectation is that the most responsible individual at manufacturing sites be involved in inspections. The agency is increasingly talking about its “responsible corporate official” or Park Doctrine powers to hold top officials responsible for manufacturing issues and problems.
Happy New Year – or not! Firms inspected by US FDA since Oct. 1 will receive word within 90 days whether their facilities received passing – or failing – grades under timelines mandated by GDUFA II and incorporated into the agency's new Concept of Operations agreement, FDA officials tell FDLI meeting.
ICH expert working group is encountering challenges in setting permitted daily exposure limits for elemental impurities in topical drugs, the group's rapporteur says. Nevertheless, the group is forging ahead and plans to have a Step 2 draft document ready for public consultation in May.
A group of regulatory authorities has published guidance for harmonizing members' reviews of active substances in drug applications so that it could be adapted for regulatory convergence worldwide – and so that generic drug firms could use it to anticipate regulatory expectations.
Pharmaceutical manufacturers finally have some clarity on how and when un-serialized drug products can be grandfathered under DSCSA.
US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.