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CDER and CBER issued a joint data standards strategy detailing how the centers will develop and use data standards to review pre- and post-market safety and efficiency data through fiscal year 2022. Read More
Citing a public health emergency, a group of congressional Democrats called on HHS Secretary Alex Azar to use existing legislative authority to lower the price of hepatitis C virus treatments. Read More
Taking some opioid painkillers increases the risk of deadly infections, according to an analysis of data from TennCare, Tennessee’s state Medicaid program. Read More
Although 2017 saw significantly fewer new FDA regulations, other regulatory and enforcement activities at the agency built on existing long-term trends, according to a new report from PriceWaterhouseCoopers (PwC). Read More
Biocom recommended the guidance “provide greater clarity on the level of evidence required for RMAT designation” compared to breakthrough and fast-track designations. Read More
The draft guidance considers the appropriateness of pursuing an indication in a disease’s molecular subset depending on whether patients with the genetic alteration are more likely to respond to the targeted therapy. Read More
The state declined to refund the federal share of ineligible claims and said all rebate-eligible drugs would be properly invoiced eventually. Read More
The FDA served U.K. drug manufacturer Bray Group a Form 483 after finding numerous violations during an inspection of the firm’s Faringdon, Oxfordshire facility, including problems with validations, sample testing, cleaning and maintenance. Read More
The FDA’s Office of Prescription Drug Promotion sent an untitled letter to Collegium Pharmaceutical of Canton, Massachusetts for downplaying the risks of its extended release opioid drug Xtampza ER in an exhibit booth at an American Society of Health-System Pharmacists meeting last summer. Read More
A federal judge ruled in favor of the FDA’s decision to deny Amgen market exclusivity for the pediatric dialysis drug Sensipar (cinacalcet), saying the company failed to prove the FDA applied different standards in its review. Read More