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The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More
Pfizer will allow Teva to launch a generic of Viagra in the U.S. in 2017 — more than two years before the final patent on the drug expires — under a deal that settles a long-running patent flap. Read More
PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More
HHS stands by its final rule expanding the discounts for orphan drugs that hospitals and healthcare providers can apply when used to treat non-rare diseases, the agency said in a court filing opposing PhRMA’s attempts to invalidate the rule. Read More
The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing last week that outlines how it intends to approach one contentious issue involving compounders. Read More
Looking to add to its growing skin care product portfolio, Valeant Pharmaceuticals said Monday it will acquire medical devicemaker Solta Medical for $250 million. Read More
Drugmakers should review the marketing contracts they have in place with pharmacies or other third parties to ensure the information they send to patients complies with new HHS limitations. Read More
U.S. lawmakers Wednesday introduced a bill that would prohibit patent litigation settlements in which a brand drugmaker compensates a generic drugmaker to delay sales of a competing generic drug, commonly referred to as “pay-for-delay” deals. Read More
The House late Thursday passed a comprehensive budget deal that, in easing some of the pain of sequestration, puts the FDA’s fiscal 2014 outlook in the hands of congressional appropriators typically friendly to the agency. Read More