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An increased number of generic appeals has led CDER to transfer the management of its Formal Dispute Resolution program for sponsors of user fee products from the Office of New Drugs to the Office of Executive Programs, CDER Director Janet Woodcock said in a staff memo. Read More
The House will take up nearly five dozen bills on the opioids crisis and the Senate will hear from HHS Secretary Alex Azar on drug prices in what will be a busy week for drug legislation and policy on Capitol Hill. Read More
FDA Commissioner Scott Gottlieb said the agency is “pursuing new policy steps to help make it more feasible for compounders to meet the requirements of becoming an outsourcing facility.” Read More
The agency plans to issue proposed rule to require a new form of patient labeling for prescription drugs dispensed or administered on an out-patient basis. Read More
The FDA’s draft guidance on inclusion of pregnant women in clinical trials needs some fine tuning, according to stakeholders, including more clarity on non-adherence to therapies. Read More
The Federal Trade Commission filed an amicus brief in the case of Takeda v. Zydus, urging the U.S. District Court of New Jersey to reject the notion that patent infringement suits brought under a law governing generic drugs are exempt from antitrust scrutiny. Read More
Within weeks of the approval of Pfizer’s biosimilar in 2016, J&J implemented a plan to maintain its market share, according to the complaint. Read More