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The FDA slapped a German contract manufacturer with a Form 483 for serious data integrity violations found in an inspection of its facility in Bavaria. Read More
The FDA details how sponsors of nonclinical safety evaluations of new drugs and therapeutic proteins should consider their impact on the immune system, in a draft guidance released yesterday. Read More
A coalition of unions and patient advocacy groups has urged the Federal Trade Commission to strengthen its requirements for AbbVie and Allergan’s planned $63 billion merger. Read More
The Attorneys General of a dozen states and the U.S. Chamber of Commerce have urged a federal appeals court to dissolve the novel “negotiating class” in the multidistrict opioid litigation, arguing that Judge Dan Polster of the U.S. District Court for the Northern District of Ohio lacked the legal authority to create it. Read More
A federal judge in Massachusetts ruled that seven former Insys Therapeutics executives must pay nearly $57 million in restitution for their role in the company’s scheme to boost prescriptions of its sublingual fentanyl spray Subsys. Read More
Sen. Chuck Grassley (R-Iowa) said he expects his drug pricing bill S. 2543 to pass in the Senate by May 20, just two days before the deadline to renew expiring healthcare programs. Read More
The FDA and the government of India stopped hundreds of shipments of illicit prescription drugs and combination products from entering the U.S. during their first joint enforcement operation, the two regulators announced yesterday. Read More