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A top FDA generic drug official said the agency is implementing various initiatives to improve the way it communicates with manufacturers, including through the revision of an internal document on staff interactions with industry. Read More
Manufacturers seeking approval of biosimilars in Europe will be able to use comparator biologics authorized outside the EU to gain marketing clearance. Read More
Manufacturers of forthcoming biosimilars argue that their products should have the same international non-propriety name (INN) as the reference product, and do not need a unique qualifier to distinguish them from the brand version for the purposes of tracking. Read More
Generic drugmakers want the FDA to better define what qualifies for a “controlled correspondence” under a draft guidance that aims to speed agency responses to manufacturer queries. Read More
The FDA has made progress addressing its looming ANDA backlog, assigning 65 percent of the languishing applications a targeted action date, say top agency officials, who add that new generic drug review processes will improve response rates going forward. Read More
The FDA wants to improve the way it communicates with sponsors of investigational new drug applications and is seeking industry and academia’s advice on how to accomplish that goal. Read More
Merck’s cancer drug Keytruda has received its second FDA breakthrough therapy designation, this time for advanced non-small cell lung cancer. Read More
Singapore would ban all direct-to-consumer advertisements for prescription drugs under a set of proposed advertising rules scheduled to take effect late next year. Read More
Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development. Read More
European Medicines Agency evaluators have recommended labeling updates for Roche’s rare lung disease therapy Esbriet to include information on the drug’s mortality benefit. Read More