The FDA offers several pathways to expedite approval of new drugs to help get them to market much more quickly while still evaluating their safety. Source: Drug Industry Daily

The FDA has laid out its current thinking on the adhesive performance and irritation potential of generic transdermal and topical drug delivery systems and clarified recommendations for designing safety and…

Arbutus Biopharma — which has been going after makers of the two messenger RNA (mRNA)-based COVID-19 vaccine makers alleging patent infringement — suffered a loss this week when a U.S.…

Multiple devices and digital behavioral interventions have been approved or are in the works to help patients suffering from opioid use disorder (OUD), says FDA Commissioner Robert Califf, but obstacles…

New FDA drug approvals in the past month include treatments for rare diseases and an aggressive form of skin cancer, as well as the first new treatment for invasive fungal…

The FDA offers expanded advice for sponsors on risk-based monitoring of clinical trials in a new final guidance that updates the agency’s previous guidance on the topic issued in 2013.…

The FDA has launched a pilot program that promises faster product reviews for manufacturers who switch to new sterilization methods. Source: Drug Industry Daily

While Congress may have ended the “national emergency related to the COVID-19 pandemic” with a joint resolution President Biden signed into law on Monday, the public health emergency (PHE) declared…

Bookshelves in Washington are filled with expert reports that have never been read and with recommendations that have never been implemented. Source: Drug Industry Daily

As two dueling lawsuits over the FDA-approved medical abortion drug mifepristone appear headed to the U.S. Supreme Court, hundreds of drugmakers say Friday’s ruling in the Texas case is an…