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Additionally, 21 member states impose penalties for falsification across the manufacturing supply chain, including manufacturing, distribution, brokering, import, export and sale at a distance. Read More
Researchers at the FDA and the Centers for Medicare and Medicaid Services are considering whether a cell-based influenza vaccine might be more effective than the egg-based vaccine that did not prove very effective against this year’s H3N2 flu strain, according to Commissioner Scott Gottlieb. Read More
The Justice Department is creating a task force to combat the opioid crisis and plans to file a Statement of Interest in multidistrict litigation against distributors and manufacturers of opioids, according to Attorney General Jeff Sessions. Read More
The U.S. Department of Justice filed a complaint against Patient Care America, a Pompano Beach, Florida compounding pharmacy, claiming the firm made illegal payments to secure prescriptions for drugs reimbursed by TRICARE — the federally-funded health care program for military members and their families. Read More
In another blow to Allergan’s efforts to retain exclusivity for its dry-eye drug Restasis, the U.S. Patent Trials and Appeals Board said Allergan’s transfer of the patents to the St. Regis Mohawk tribe last year conferred only “illusory rights” and denied the company’s motion to terminate Mylan’s challenge to six of its patents. Read More
HHS Secretary Alex Azar said the FDA plans to expand the use of medication-assisted treatments for opioid addiction and will soon issue two new guidances on the topic. Read More
Aevi Genomic Medicine commented that “the proposed remedy is likely to impede and delay development of important new medicines for children.” Read More
The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should be provided in authorization applications for starting materials. Read More
A former Horizon Pharma senior director sued the drugmaker, claiming she was fired for raising concerns about off-label drug promotion at a previous employer. Read More