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Opioids

November 02, 2018 | Daily News

Despite opposition from public health advocacy groups and the chair of one of its own advisory committees, FDA on Friday (Nov. 2) approved a new sufentanil sublingual drug-device combination tablet that is five to 10 times more potent than fentanyl, while promising to revisit how it reviews new opioids moving forward.

November 02, 2018 | Daily News

FDA’s psychopharmacologic drugs and drug safety advisory committees, in a joint meeting on Thursday (Nov. 1). voted against approval of a proposed new opioid combination drug indicated to treat major depressive disorder.

November 02, 2018 | Daily News

A new relationship between FDA and the Department of Defense (DOD) went official Friday (Nov. 2) with the announcement of a memorandum of agreement (MOU) that will formalize a framework agreed upon in January, under which FDA will work with DOD to accelerate access to medical products for the military.

October 29, 2018 | Daily News

CMS told states they do not need to defray the costs of new benefits that may be included in a revised essential health benefit (EHB) benchmark plan unless the coverage has been legislatively mandated, and encouraged states to implement revisions that would better address the opioid epidemic.

October 29, 2018 | Daily News

In a recent report, the Institute for Clinical Economic Review (ICER) determines that extended-release formulations of medications used to treat opioid use disorder cost much more than generic buprenorphine/naloxone while providing only marginal clinical benefit.

October 25, 2018 | Daily News

Two California men have pleaded guilty to conspiring to defraud Affordable Care Act plans in at least 12 states by enrolling people in coverage and transporting them to expensive drug treatment facilities in California that paid referral and other fees, the Department of Justice announced.

October 24, 2018 | Daily News

President Donald Trump on Wednesday (Oct. 24) signed into law the massive bicameral package of opioid legislation, which the Senate passed Oct. 3.

October 23, 2018 | Daily News

FDA will ask two of its advisory committees to weigh in on expanding the availability of naloxone for use in the community during a two-day meeting Dec. 17 and 18, the agency announced Tuesday (Oct. 23).

October 23, 2018 | Daily News

The head of FDA's anesthetic and analgesic advisory committee has joined consumer group Public Citizen in urging FDA to reject approval of AcelRx's DSUVIA, a sufentanil sublingual drug-device combination tablet that is five to 10 times more potent than fentanyl.

October 19, 2018 | Daily News

HHS Secretary Alex Azar touted the agency's Regulatory Sprint to Coordinated Care on Wednesday (Oct. 17), including upcoming work on 42 CFR Part 2 privacy requirements, and the administration’s fall unified agenda indicates the Substance Abuse and Mental Health Services Administration intends to publish a proposed rule on the privacy requirements next year.

October 19, 2018 | Daily News

FDA wants to help health care providers better understand the different levels of potency across opioid medications, FDA Commissioner Scott Gottlieb said Thursday (Oct. 18).

October 18, 2018 |

FDA plans to “very quickly” begin implementing requirements that opioid makers package their drugs in unit-dose packaging to provide for shorter duration prescriptions, such as one or two days, agency commissioner Scott Gottlieb said Thursday (Oct. 18).

October 18, 2018 | Daily News

FDA plans to “very quickly” begin implementing requirements that opioid makers package their drugs in unit-dose packaging to provide for shorter duration prescriptions, such as one or two days, agency commissioner Scott Gottlieb said Thursday (Oct. 18).

October 17, 2018 | Daily News

Deputy Attorney General Rod Rosenstein praised the recently-passed opioid bill and said the Department of Justice is beefing up criminal prosecutions and civil penalties against over-prescribers of opioids and illegal distributors of synthetic opioids.

October 16, 2018 | Daily News

An FDA advisory committee on Friday (Oct. 12) determined that the benefits of a proposed new sufentanil sublingual tablet support the product's approval, overriding three panel members who disagreed.

October 03, 2018 | Daily News

The Senate cleared a massive bicameral package of opioid legislation on Wednesday (Oct. 3) by a vote of 98-1, with Sen. Mike Lee (R-UT) as the sole “no” vote, and Sen. Ted Cruz (R-TX) not voting.

September 28, 2018 | Daily News

The sweeping opioid deal passed by the House Friday (Sept. 28) includes new language aimed at closing a loophole in separate gag-order legislation that requires makers of biologics to report to the Federal Trade Commission settlements that could delay biosimilar competition.

September 27, 2018 | Daily News

A partial repeal of the Medicaid IMD exclusion in the final opioid bill agreed to by the House and Senate conference negotiators will cost the federal government just over $1 billion over 10 years, the Congressional Budget Office said Thursday (Sept. 27).

September 27, 2018 | Daily News

A provision expanding the sunshine law to require drug and medical device makers publicly disclose payments made to health care providers beyond doctors made it into the final version of an opioid bill unveiled by House and Senate negotiators on Tuesday (Sept. 25), despite opposition from the medical device lobby.

September 26, 2018 | Daily News

The final opioid legislation unveiled by House and Senate negotiators late Tuesday (Sept. 25) includes two controversial provisions -- one expanding Medicaid payments for opioid-abuse treatment in large inpatient facilities and another allowing non-physician providers to prescribe a drug used to treat opioid addiction.

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