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The collection, use and submission of patient experience data (PED) still requires significantly more FDA guidance, clarification and support, big-name sponsors told the agency in response to a request for information and comments on the subject. Read More
The Senate Finance Committee has advanced a bill seeking to reform pharmacy benefit managers (PBMs) by prohibiting them from deriving compensation for Medicare Part D-covered drugs based on the drug’s list price, among other proposals. Read More
HHS announced plans to issue several FDA-related proposed and final rules in the coming year in its semiannual inventory of rulemaking actions. Read More
While prescription drug user fees increased a hefty 19.9 percent and medical device fees a modest 8.7, fees for biosimilar applications dropped up to an eye-popping 373 percent. Read More
Teva has filed a motion in district court seeking a trial postponement while an interim appeal is ongoing, the latest in a back-and-forth with the Department of Justice (DOJ) which has accused the Israeli drugmaker of defrauding Medicare via a Copaxone (glatiramer) kickback scheme involving charitable foundations. Read More
The FDA has issued a final guidance outlining a program that allows stakeholders to propose pharmaceutical quality standards for recognition by CDER, providing industry with additional resources for pharmaceutical development and manufacturing. Read More
Drug-device combination products can pose cumbersome regulatory challenges for companies, say regulatory experts, primarily because the product has to comply with two complicated regulatory systems that are not designed to work together. Read More
Recalls can be messy, complicated matters, especially for manufacturers that don’t have a plan in place for analyzing a problem, determining a course of action and carrying out all recall-related tasks in compliance with FDA requirements. Read More
The FDA has issued final guidance on assessment and control of DNA reactive impurities in harmony with guidance prepared by the International Council for Harmonisation (ICH). Read More