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FDA Commissioner Scott Gottlieb announced that the agency has developed easy-to-understand model drug facts labels (DFLs) to encourage drugmakers to develop an OTC version of the opioid overdose treatment naloxone. Read More
The FDA released two draft guidances outlining the agency’s latest thinking on assessments of risk evaluation and mitigation strategy (REMS) programs. Read More
The FDA announced that the impurities found in valsartan-containing blood pressure drugs may have been caused by specific chemicals and reaction conditions in the manufacturing process of the drug’s API. Read More
The FDA reopened on January 25 following a 35-day partial shutdown of the federal government that curtailed the agency’s inspection activities that did not directly tie into public safety. Read More
CDER released its latest annual report on drug safety priorities, detailing how it approached drug safety in 2018 — including how it handled the valsartan impurity crisis. Read More
“Having timely, accurate information about what drugs are being actively marketed helps provide transparency around circumstances where generic competition is lacking,” Gottlieb said. Read More
Scilex noted that numerous over-the-counter lidocaine patches that do not conform to the FDA’s 1983 tentative final monograph are being marketed. Read More
Sen. Bernie Sanders (I-Vt.) took aim at Florida-based drug developer Catalyst Pharmaceutical over what he called the “staggering” list price for Firdapse (amifampridine), a treatment for a rare neuromuscular disease that the company plans to launch in the first quarter of 2019. Read More
A California judge ruled in Boehringer Ingelheim’s favor in another court case involving its blockbuster blood thinner Pradaxa (dabigatran) and allegations of fraud and failure to warn about the drug’s risks. Read More