International Pharmaceutical Regulatory Monitor

Drugs targeting the central nervous system take significantly longer to develop and get approved than other meds, according to a new analysis. Source: International Pharmaceutical Regulatory Monitor

A newly unsealed lawsuit accuses AstraZeneca of using nurses to covertly promote its products, echoing a similar complaint against AbbVie. Source: International Pharmaceutical Regulatory Monitor

FDA Commissioner Scott Gottlieb announced a revised agreement between the agency and states on interstate distribution of compounded drugs, responding to concerns that the existing distribution limits are too low. Source: International Pharmaceutical Regulatory Monitor

FDA Commissioner Scott Gottlieb announced a revised agreement between the agency and states on interstate distribution of compounded drugs, responding to concerns that the existing distribution limits are too low. Source: International Pharmaceutical Regulatory Monitor

Janssen and Takeda called for more flexibility in the FDA’s draft guidance for sponsors of drugs that treat major depressive disorder (MDD). Source: International Pharmaceutical Regulatory Monitor

The FDA released final guidance for drug sponsors on the content and formatting of physiologically-based pharmacokinetic (PBPK) analyses, including an expanded section on formatting and a simplified section on software. Source: International Pharmaceutical Regulatory Monitor

Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to win FDA approval, the agency says in a new draft guidance. Source: International Pharmaceutical Regulatory Monitor

Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to win FDA approval, the agency said in a new draft guidance. Source: International Pharmaceutical Regulatory Monitor

The Association for Accessible Medicines urged the FDA to clarify its draft guidance on Drug Supply Chain Security Act (DSCSA) waivers by adding an estimated timetable for review decisions. Source: International Pharmaceutical Regulatory Monitor

The Pharmaceutical Care Management Association is concerned about a proposed rule that could remove safe harbor protections for pharmaceutical company rebates and significantly change how U.S. drug prices are formulated. Source: International Pharmaceutical Regulatory Monitor