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Sen. Claire McCaskill (D-Mo.) introduced a bill that would repeal 2016 legislation that she believes weakened the Drug Enforcement Administration’s ability to go after opioid distributors. Read More
A shift to more expensive settings can mean higher costs for Medicare beneficiaries and privately insured patients who pay a portion of the treatment charges. Read More
According to the complaint, the labels understate the percentage of users the symptoms effect at only 1 or 2 percent, when in fact it is closer to 50 percent. Read More
The FDA’s draft guidance on post-approval manufacturing changes for biological products needs work to clarify how it fits with previous agency documents, according to written comments on the draft, which were due last week. Read More
Health Canada has proposed fee hikes for reviewing applications for approval of new drugs, for oversight of drug manufacturing facilities, for postmarket monitoring of drug sales and for other regulatory activity. Read More
Finger-pointing abounded Tuesday in a Senate hearing on prescription drugs prices, where branded and generic drug industry representatives testified alongside pharmacist, wholesale distributor and benefit manager groups. Read More