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The number of patent lawsuits filed over generic drug challenges has spiked this year, a development that coincides with the widely anticipated “patent cliff” of many brand drugs losing protection. Read More
The entire class of prescription and over-the-counter proton pump inhibitors do not require a boxed warning, but some prescription PPIs should contain a medication guide, the FDA said in response to a long-waiting citizen petition. Read More
The FDA is asking drugmakers to use the data universal numbering system (DUNS) to register their manufacturing facilities in the U.S. and abroad. Read More
An HHS watchdog will audit how the FDA inspects generics manufacturing facilities, oversees postmarketing studies and ensures compliance with clinical trial reporting requirements, as well as how the drug industry is implementing the track-and-trace law. Read More
The Republican landslide in Tuesday’s midterm election will put GOP lawmakers in the driver’s seat on the generics labeling rule, user-fee negotiations and agency funding, but experts say the political shift’s impact remains uncertain. Read More
Drugmakers participating in an ISPE pilot program on quality metrics received new guidance on what data they need to collect, information that could provide a glimpse of the kinds of data that the FDA will start collecting next fall. Read More
For the first time, pharmaceutical manufacturers will have to report certain financial payments to continuing medical education programs (CME) under the Physician Payments Sunshine Act. Read More
Sales of orphan drugs are expected to grow more than twice as fast as non-orphan drugs in the U.S., Europe and Japan in the coming years, as drugmakers take advantage of lower costs for clinical trials and higher prices when products launch, a new report shows. Read More
The UK’s health care costs regulator has recommended coverage of GlaxoSmithKline’s Arzerra as a cost-effective option for untreated chronic lymphocytic leukemia (CLL), offering another drug for treating the most common form of leukemia in England. Read More
The FDA is seeking industry feedback on burdens related to its regulations of clinical investigations on the safety and effectiveness of unapproved new drugs and biologics. Read More
Bio-Rad Laboratories agreed to pay $55 million to settle federal investigations charging its subsidiaries bribed foreign officials in Russia, Vietnam and Thailand to win business. Read More