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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
Amgen is asking the FDA to require that all biosimilar filers send a full copy of their application to the innovator company, a position that parallels the company’s lawsuit opposing Sandoz’s bid to make a version of its chemotherapy product Neupogen. Read More
In a temporary win for generics manufacturers, the FDA says it will delay its controversial generic drug labeling rule by nine months while it reviews 119 comments it received about the measure. Read More
HHS decided not to issue an all-encompassing regulation on the 340B drug pricing program as intended, but will keep in place its earlier interpretive rule that requires manufacturers to provide certain orphan drugs at discounts of up to 50 percent. Read More
Pharmaceutical companies today spend an average of $2.6 billion to get their products to market, according to a new report that finds R&D costs have increased 145 percent over the past decade. Read More
Inspections of U.S. pharmaceutical manufacturing facilities have seen a declining number of official warnings over the past five years, but the trend is less clear on the international front. Read More
Companies developing vaginal microbicide gels to prevent HIV infections should have a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue in human studies evaluating the safety and tolerability of the products, says a new final guidance. Read More
Ranbaxy is fighting to reclaim its first-filer generic exclusivity on AstraZeneca’s blockbuster heartburn drug Nexium with a lawsuit challenging the FDA’s recent decision to rescind tentative ANDA approval for the therapy over manufacturing violations. Read More
The FDA has proposed criteria for how an ANDA can receive an expedited review under the “first generic” review prioritization category, a move the agency hopes will ease industry confusion over the generic drug incentive. Read More
Generics firm Pliva has asked the U.S. Supreme Court to throw out a decision by Iowa’s highest court that potentially paves the way for the company and other generics makers to be held liable in failure-to-update-label claims. Read More