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The FDA’s proposal that drugmakers add microbiology and pharmacogenics information to product labels should apply only to new prescription drugs and biologics, said industry experts. Read More
A story in the Oct. 15th issue of DID incorrectly stated that the U.S. had introduced a framework this month for drugmakers to report payments to physicians and teaching hospitals. The article should have said a website for reporting such data under the Sunshine Act went live this month. Read More
A trade group of small to medium-sized European brand drugmakers has criticized a Spanish government order that may allow biosimilars to be interchanged with their reference product in the same way that generics may be substituted for brands. Read More
A UK healthcare cost watchdog has recommended against national coverage of Dendreon’s novel prostate cancer treatment Provenge, deeming it too expensive. Read More
Drug sponsors conducting a clinical trial should take efforts to better understand the effects of a particular disease on patients when designing ways to measure patient-reported outcomes, says an FDA clinical trials official. Read More
Six months of additional pediatric exclusivity should be granted only to products that add a children-specific indication, and only if the drug sponsor receives a specific written request from the FDA for studies to support the label expansion, according to the American Academy of Pediatrics. Read More
The FDA late Wednesday approved two breakthrough therapies for idiopathic pulmonary fibrosis: Boehringer Ingelheim’s Ofev and Intermune’s Esbriet, both of which are set to hit the market within the next two weeks, the companies said. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
Drugmakers should upgrade their quality assurance systems to quickly identify and fix any manufacturing problems that could spiral into a shortage, according to a wide-ranging plan to address shortfalls in drug supplies. Read More
Regulators in Brazil have unveiled the country’s first drug-tracking platform, a key piece of infrastructure that will connect Anvisa and drug registration holders as they implement the country’s 2013 National Drug Control System. Read More