U.S. officials seized more than 12 tons of illicit opioids at ports of entry between 2013 and 2017, according to a new report that bolsters FDA Commissioner Scott Gottlieb’s call…

Orphan drug development takes 18 percent longer to reach the product launch stage than new drugs across the board, according to a new analysis from the Tufts Center for the…

An FDA advisory committee voted 12 to 8 Thursday that Akcea Therapeutics’ NDA for treatment of a rare genetic disease demonstrated safety and efficacy. Source: Drug Industry Daily

As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are…

Australia’s Therapeutic Goods Administration revised its guidelines for confidentiality obligations and conflicts of interest for members of advisory committees, overhauling the guidance with major content and structural changes. Source: Drug…

Ahead of an anticipated speech on drug pricing by President Trump on Friday, a group of House Democrats spelled out their own list of actions needed to deal with the…

The FDA invited comments from stakeholders on a new draft guidance for clinical trial designs and drug development programs to support indications for uncomplicated urinary tract infection (uUTI) treatments. Source:…

HHS unveiled its spring unified agenda for upcoming proposed and final rulemakings Wednesday. Source: Drug Industry Daily

Novartis paid more than $1 million to a shell company controlled by President Trump’s embattled attorney, and the company confirmed it discussed the matter with Special Counsel Robert Mueller. Source:…

The FDA warned Phase 4 Pharmaceutical for repackaging deficiencies and inadequate drug distribution procedures at its Aventura, Florida facility. Source: Drug Industry Daily