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The FDA is giving industry until March 9 to again weigh in on the controversy surrounding generic first-filer exclusivity determinations and other GDUFA-related issues first raised at a September public hearing. Read More
Long-awaited guidance on designating a biosimilar as interchangeable with the reference product may soon be in the offing, based on an FDA request for comments on a proposed collection of information. Read More
The FDA has again found Upsher-Smith Laboratories’ testosterone gel Vogelxo therapeutically equivalent to Auxilium’s Testim — knocking down Auxilium’s citizen petition demanding higher hurdles for 505(b)(2) NDAs aimed at its therapy. Read More
After serving as FDA commissioner for six years, Margaret Hamburg has resigned, ending a tenure during which the agency boosted its focus on drugs for unmet needs, strengthened policing of compounding pharmacies and increased drug approvals. Read More
A proposal to lift restrictions on how drugmakers can promote products on social media and another that would grant up to 15 years of generics-free exclusivity to drugs approved to treat an unmet medical need are emerging as controversial issues in a proposal to overhaul the FDA’s drug approval processes. Read More
Drugmakers claiming a product is protected by a patent will need to make much more detailed justifications of their claims under a rule proposed by the FDA on Feb. 5. Read More
The UK’s health cost-effectiveness watchdog is recommending coverage of Norgine’s Targaxan to treat adults with a serious and potentially life-threatening brain condition caused by liver failure. Read More
CDER Director Janet Woodcock has tapped Jonathan Jarow for a 120-day stint as acting director of the Office of Medical Policy, effective Feb. 23. Read More
Injectables giant Hospira is launching its Remicade biosimilar Inflectra in at least 10 new European markets, nearly doubling the product’s presence on the continent. Read More
The FDA is seeking additional comment from industry on its highly controversial proposed rule giving generics makers the same authority brandmakers have to update their product labels without agency approval when new safety information about a drug emerges. Read More
The FDA is pushing ahead with efforts to spur development of hard-to-copy generics, this time sponsoring research into bioequivalence testing for long-acting periodontal drugs and developing methods for assessing generic, long-acting injectables. Read More