The FDA finalized guidance outlining clinical trial designs for hypogonadotropic hypogonadism treatments, recommending efficacy endpoints and enrollment criteria. Source: Drug Industry Daily

Institutional Review Boards must comply with the Code of Federal Regulations in their written procedures but they have some flexibility with regard to the format and content, according to new…

In a marathon markup on Thursday, the House Energy & Commerce Committee advanced more than 30 bills to address the opioid crisis. Source: Drug Industry Daily

In an effort to curb the “gaming tactics” that delay generic drug competition, the FDA released a public list of companies found to be potentially restricting access to samples of…

The FDA’s guidance on developing Alzheimer’s drugs is overly rigid when it comes to enrollment of patients in clinical trials, drugmakers said in public comments. Source: Drug Industry Daily

The FDA took vendor IQVIA to task for a discrepancy in data regarding sales of opioid drug products that the agency said could undermine forecasts used in the fight against…

The Center for Medicare & Medicaid Services issued a long-awaited update to its online dashboard, increasing drug price transparency for consumers by adding year-over-year drug pricing changes and price-hiking manufacturers.…

Clinical trial sponsors must step up their efforts to address underrepresentation of women among trial subjects, said FDA Commissioner Scott Gottlieb Wednesday during a meeting in White Oak, Maryland to…

Vermont’s governor Phil Scott signed a bill Wednesday to allow wholesalers to import drugs across the Canadian border. Source: Drug Industry Daily

The increased use of fast track regulatory pathways has led to the FDA having the shortest median approval time for new active drug substances in 2017 compared to five other…