The FDA released a trio of guidances Wednesday on Drug Supply Chain and Security Act (DSCSA) requirements for drugmakers to attach identifiers to their prescription drugs. Source: Drug Industry Daily
The FDA hit Rotterdam, Netherlands-based drugmaker Fagron for inadequate drug product storage and procedures for controlling recalled products at the firm’s Saint Paul, Minn., facility. Source: Drug Industry Daily
The Senate passed legislation Monday that would bar PBMs or insurers from including gag clauses in their contracts with pharmacies, sending the bill to the House by a vote of…
Lawmakers are hoping to quickly reconcile the Senate’s newly-passed Opioid Crisis Response Act (S. 2680) with the package the House passed as soon as Friday and vote through a final…
The FDA Tuesday added immediate-release opioids to its risk evaluation and mitigation strategy (REMS) for opioid analgesics, saying the move will encourage “rational prescribing.” Source: Drug Industry Daily
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.…
Janssen and Takeda called for more flexibility in the FDA’s draft guidance for sponsors of drugs that treat major depressive disorder (MDD).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.…
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…
The Senate Monday — by a 99 to 1 margin — passed a bipartisan legislative package targeting the opioid crisis. The move comes on the heels of House passage of…