The FDA today approved the first non-opioid treatment designed to help manage the symptoms of opioid withdrawal in adults. The drug, Lucemyra, isn’t a treatment for opioid use disorder, the agency noted. Instead, it is meant to be used as part of a broader plan to help adults manage their symptoms when they stop using […]
FDA
FDA chief suggests kickback law could be used to rein in drug prices
Drug rebates paid between pharmaceutical companies and pharmacy benefit managers enjoy safe harbor status under federal kickback law, leaving them immune from legal scrutiny. But that could change, FDA chief Dr. Scott Gottlieb suggested yesterday at the FDA Law Institute’s annual meeting. The commissioner reportedly hinted that reinterpreting the law could help lower drug prices. […]
FDA issues draft guidance for the use of diagnostics in cancer drug trials
The FDA issued draft guidance this week describing a streamlined submission process to determine whether using an in vitro diagnostic in a cancer drug’s clinical trial poses a significant or nonsignificant risk. The agency wrote that sponsor should use the proposed pathway when possible “to reduce administrative burden on sponsors and FDA and to maintain […]
Report: FDA guidance ‘fraught with potential complications’ for drug-device products
The FDA issued revised guidance documents earlier this year clarifying the agency’s ‘Refuse to Accept’ policy for 510(k)s and PMAs. The updated policy raises questions for companies developing and submitting combination products for regulatory approval, according to lawyers Allyson Mullen and Rachael Hunt. The associate partners detailed changes to the components that companies must include […]
FDA aims to curb ingredient list for drug compounders
The FDA issued draft guidance last week designed to limit the list of pharmaceutical ingredients that drug compounding pharmacies can use to manufacture drugs in bulk that do not undergo the agency’s traditional approval process. The move comes in the wake of a deadly 2012 fungal meningitis outbreak that originated from contaminated drugs made in […]
With weeks left in flu season, the FDA is already working on next year’s vaccine
There are still weeks left in this year’s flu season, according to the FDA, but the agency is already planning on how to better protect the nation’s public health next year. An initial report from the Centers for Disease Control and Prevention concluded that this year’s flu vaccine sported a 36% efficacy rate. Although that’s […]
The flu season is making a shortage of IV fluids worse – here’s what the FDA is doing about it
This year’s flu season has been exceptionally bad – it’s already claimed the lives of dozens of kids and it’s more widespread than any other year on record, according to the Centers for Disease Control and Prevention. It’s also making a shortage of intravenous fluids and IV bags worse than it already is. IV saline […]
FDA, FTC warn companies over deceptive opioid cessation products
The FDA and the Federal Trade Commission have posted joint warning letters to companies that make and distribute opioid cessation products. The two watchdogs warned that the companies are illegally marketing their unapproved products as treatments or even cures for people with opioid addiction and withdrawal. Selling unapproved products as therapies for opioid addiction is […]
Governor passes law to keep birth control free in Massachusetts
Massachusetts governor Charlie Baker signed a law on Monday requiring health insurers to cover at least one kind of every type of FDA-approved birth control. The new law protects health care services and rights for women across the state, “irrespective of what goes on in Washington,” the Republican governor said at the bill’s signing, according […]
FDA wants to improve access to generic abuse-deterrent opioids: here’s how
The FDA commissioner, Dr. Scott Gottlieb, has made the opioid crisis a priority in his time at the agency. Yesterday, the regulatory body issued guidance to help promote the development of generic opioids designed to prevent abuse. To date, the FDA has approved 10 of these products, called abuse-deterrent opioids. But, as Gottlieb noted in […]