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Latest From Review Pathway
Novel approvals by US FDA in 2017 could easily surpass the 28 agents approved by the agency's drug and biologics centers in 2016. The big question is whether last year's spike in complete response letters was an anomaly or the start of a trend.
All marketing approval applications submitted via Europe’s decentralized procedure are being processed under a new pilot that should help regulators validate applications faster. The pilot might also give companies a better understanding of the validation process and how omissions or mistakes in their documentation might invalidate or delay their applications.
US agency's Associate Director for Therapeutic Biologics Leah Christl gives the most up-to-date snapshot of biosimilar regulatory development, the potential areas for further FDA collaboration with European regulators – and how long it may be until the agency approves the first interchangeable biosimilar.
Qualified Infectious Disease Product Designations granted by FDA. Updated upon new designations.
Excitement to get a 10-month ANDA review may have waned in January as submissions plummet, but can approvals keep up?
In meeting with PhRMA, president says FDA approval must be faster and that a commissioner pick is coming.
As part of a flurry of actions in the waning days of the Obama Administration, FDA formally announced a process for requesting the new “Regenerative Advanced Therapy” designation. Much like the early days of “Breakthrough,” the standards are uncertain for now.
US FDA approves Teva’s fluticasone/salmeterol fixed-dose combination product under the 505(b)(2) NDA route with an asthma indication but no labeling claim for chronic obstructive pulmonary disease.
Bristol's filing of Yervoy/Opdivo in first-line lung cancer is delayed as the company drops its plans for accelerated approval, but could be on a more solid regulatory footing if the pivotal trial is successful. Meanwhile, AstraZeneca is using adaptive trial design to update MYSTIC, which could result in broader approvals.
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