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The FDA is working with providers, manufacturers and distributors to head off potential saline shortages during flu season, FDA Commissioner Scott Gottlieb said Thursday. Read More
The Association for Accessible Medicines’ Biosimilars Council submitted an amicus brief supporting Pfizer in its antitrust lawsuit against Johnson & Johnson, arguing the company’s practices will keep biologics prices high and limit competition from biosimilars. Read More
Eighteen Democratic senators joined Health, Labor, Education and Pensions Committee Ranking Member Patty Murray (Wash.) in calling on the Government Accountability Office to review the Trump administration’s efforts against the opioid addiction crisis. Read More
The FDA proposed a new tactic in its fight against the opioid epidemic — blister packs of smaller quantities of opioid drugs that could give providers better prescription options, especially for drugs like Vicodin and Percocet usually intended for short-term use. Read More
The initiative follows previous joint efforts between the two groups that have saved participating drug plans more than CA$1 billion, or about $810 million U.S., in the last five years. Read More
In testimony before a House subcommittee Tuesday, FDA Commissioner Scott Gottlieb told lawmakers the FDA’s plans for regulating compounding pharmacies, including adapting GMP and oversight standards to a facility’s level of risk. Read More
Commonly prescribed generic drugs in Canada will see a price cut of up to 40 percent in April as part of a new initiative announced Monday by two drug industry groups. Read More
Drug sponsors seeking Qualified Infectious Disease Product and fast-track designations for antibiotics must specifically request both designations, according to a new draft guidance from the FDA. Read More