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Allergan must still face allegations that it violated the False Claims Act by incentivizing physicians to prescribe off-label Botox for pediatric migraine, although a federal circuit court judge dismissed charges that the company defrauded Medicare by promoting the practice. Source: Drug Industry Daily

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 resulting in patients taking medications incorrectly. Source: Drug Industry Daily

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 and regulations that could impact your business. Source: Drug Industry Daily

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 to lower healthcare and prescription drug costs. Source: Drug Industry Daily

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 a maintenance therapy for Crohn’s disease, Lumicell’s drug-device imaging combination for breast cancer wins regulatory clearance, and Roche’s lung cancer adjuvant therapy snags an FDA…

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 the FDA’s Form 483 levied on India-based Sun Pharmaceuticals. Source: Drug Industry Daily

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 supply and demand. Source: Drug Industry Daily

This week, the FDA announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Source: Drug Industry Daily