Yet-to-be-finalized, a proposed FDA rule to update and condense prescription medication guides for consumers, will replace current prescription info that the agency says is confusing, repetitive and conflicting — potentially…
This month we see a prospective IND for a presbyopia eyedrop, a Crohn’s flop, and wins in obstructive sleep apnea and MS. Source: Drug Industry Daily
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…
The Department of Justice (DOJ), HHS and the FTC have jointly launched a public-facing portal for reporting unfair and anticompetitive practices that the Biden administration says will support its efforts…
In this edition of Quick Notes, AstraZeneca nabs a new indication for a severe asthma drug, Alvotech and Teva win FDA approval for a Stelara biosimilar, Takeda secures approval for…
Stagnant liquid inside an air purification unit, hundreds of complaints on tablet counts and inadequate guidance to call centers are but a few of the litany of issues outlined in…
Drugmakers could make more use of regulatory intelligence to hone their approach to supplier oversight, according to one quality expert. Source: Drug Industry Daily
To detect, prevent and manage medicine shortages in the EU and European Economic Area (EEA), the European Medicines Agency (EMA) will create a new system to gather information about medicine…
This week, the FDA announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Source: Drug Industry Daily
This edition of Quick Notes looks at FDA clearances and classifications for devices involving cranial implants, Parkinson’s Disease symptoms, at-home blood sampling and robotic microsurgery. Source: Drug Industry Daily