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Opioids

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.

September 26, 2018 | Daily News

Bicameral negotiators left out of the final opioid legislation a pay-for that would have extended the time kidney-failure patients could stay on private insurance.

September 26, 2018 | Daily News

The final opioid legislation negotiated by House and Senate negotiators includes a number of FDA-focused provisions, including measures to expand the agency’s authorities in international mail facilities; allow the agency to impose certain packaging and disposal requirements for drugs that pose serious risks; and let FDA require labeling changes for drugs when new effectiveness information emerges.

September 26, 2018 | Daily News

The opioid legislation hammered out by House and Senate conferees includes a requirement that HHS, in consultation with FDA and other relevant agencies, develop materials describing the circumstances under which a pharmacist may decline to fill a prescription for a controlled substance.

September 21, 2018 | Daily News

The Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker is upset the Senate tucked into its recently passed opioid bill a provision expanding the sunshine law to require that drug and medical device makers also publicly disclose payments made to nurse practitioners, physician assistants and midwives – not just doctors and hospitals – for promotional talks, consulting and other interactions.

September 20, 2018 | Daily News

CMS on Thursday (Sept. 20) told assisters working to help people get coverage through healthcare.gov that certain victims of Hurricane Florence may qualify for an exceptional circumstance special enrollment (SEP) period that allows them additional time to enroll, and they may be eligible for other SEPs due to relocating outside of their region or other reasons.

September 20, 2018 | Daily News

HHS’ Biomedical Advanced Research and Development Authority (BARDA) has entered into a contract with Opiant Pharmaceuticals, a company that develops nasal sprays for substance use and eating disorders, to develop a fast-acting, long-lasting intranasal form of nalmefene to reverse overdose, HHS announced Thursday (Sept. 20).

September 18, 2018 | Daily News

FDA for the first time has applied its opioid safety protocols to immediate-release (IR) opioids intended for use in an outpatient setting and is requiring that training be made available to nurses and pharmacists -- not just prescribers -- who are involved managing patients with pain, the agency announced Tuesday (Sept. 18).

September 18, 2018 | Daily News

Despite being omitted from the Senate’s recently approved opioid bill, some rollback of a federal prohibition on using Medicaid funds to pay for substance-abuse treatment in large inpatient facilities may still be included in the final version of opioid legislation slated to be released in coming days, Senate aides say.

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