The FDA sent a warning letter to compounder Gipsco Investment cautioning that it’s not exempt from the agency’s oversight and was producing adulterated and misbranded products. The action stems from…
The FDA released an updated version of its 2013 Manual of Policies and Procedures (MAPP) outlining CDER’s procedures for determining pharmacologic classes for use in prescribing information for drugs. Source:…
AstraZeneca filed suit against generic manufacturer Accord Pharmaceuticals for alleged infringement upon four patents for AstraZeneca’s breast cancer drug Faslodex (fulvestrant). Source: Drug Industry Daily
CDER Director Janet Woodcock Friday announced details of two new voluntary programs designed to support improvements in product and process quality and to enhance the agency’s use of quality metrics.…
The FDA released a draft guidance Thursday recommending ways to demonstrate if new drugs or drug uses are effective for certain low-prevalence rare diseases caused by single enzyme defects. Source:…
The FDA on Thursday released its GDUFA II user fees for fiscal 2019 — including a significant hike for generic drug applicants. Source: Drug Industry Daily
An FDA advisory committee agreed Thursday that 60 Degrees Pharmaceuticals proved the safety and efficacy of its NDA for tafenoquine indicated for the prevention of malaria in adults. Source: Drug…
The FDA on Thursday issued final guidance closing a loophole under which drug sponsors could avoid their obligation to study drugs in pediatric indications. Source: Drug Industry Daily
The FDA on Wednesday published a list for drug sponsors of surrogate endpoints they may consider in trials to support drug approvals or licensures. Source: Drug Industry Daily
Two drugmakers targeted in a lawsuit over Tennessee’s opioid epidemic filed a third-party complaint against online “black market” drug distributors, alleging they’re responsible for the state’s opioid crisis. Source: Drug…